(90 days)
Not Found
No
The device description and intended use focus on physical medical devices (coils, catheters, guidewires, etc.) used for embolization and vascular procedures. There is no mention of software, algorithms, or any capabilities that would suggest the use of AI or ML.
Yes
The "Guglielmi Detachable Coils (GDC®)", "Occlusion Coils", and "Tracker® Infusion Catheter" are indicated for therapeutic purposes such as embolizing certain intracranial aneurysms, arterial and venous embolizations, obstructing/reducing blood flow, and delivering therapeutic agents. The "Stealth® Dilation Catheter" is also intended for the dilatation of peripheral vasculature, which is a therapeutic intervention.
Yes
The "Tracker® Infusion Catheter" is explicitly stated to be designed to assist in the delivery of "diagnostic agents, such as contrast media," which are used for diagnostic purposes. Additionally, the "Rotating Hemostatic Valve" is intended to support the placement of a "diagnostic catheter."
No
The device description and intended use clearly describe physical medical devices such as coils, catheters, guidewires, and other accessories used in interventional procedures. There is no mention of software as the primary or sole component of the device.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended uses described for all the listed devices (Guglielmi Detachable Coils, Occlusion Coils, Guidewires, Catheters, etc.) are for therapeutic and interventional procedures within the body (embolizing aneurysms and vascular malformations, delivering agents, dilating vessels, assisting in device delivery).
- IVD Definition: In Vitro Diagnostics are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Lack of Specimen Examination: None of the descriptions mention the examination of human specimens outside of the body.
- Focus on Intervention: The primary function of these devices is to physically interact with and modify structures within the patient's vasculature.
Therefore, these devices fall under the category of medical devices used for interventional procedures, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
- Guglielmi Detachable Coils (GDC(R)): For embolizing certain intracranial aneurysms that - because of their morphology, their location, or the patient's general medical condition - are considered by the treating neurosurgical team to be a) very high risk for management by traditional operative techniques, or b) inoperable; and for embolizing other vascular malformation such as arteriovenous malformations and arteriovenous fistulae of the neuro vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral vasculature.
- Occlusion Coils:
- Fibered Platinum Coil, .035" Type: For arterial and venous embolizations in the peripheral vasculature
- Berenstein Liquid Coil: For the embolization of vascular malformations of the peripheral, coronary and neuro vasculature.
- Occlusion Coils (except Fibered Platinum Coil .035" Type and Berenstein Liquid Coil): Coils are intended to obstruct or reduce blood flow in the peripheral and neurovasculature. They are intended for use in the interventional radiologic management of arteriovenous malformations and arteriovenous fistulas when devascularization prior to definitive surgical resection is desirable.
- Guidewires: Target Therapeutics Steerable Guidewires are designed to assist in the delivery of Tracker Infusion Catheters to selected vascular sites.
- Tracker(R) Infusion Catheter: Tracker Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and neurovasculature.
- Stealth(R) Dilation Catheter: The Stealth Dilation Catheter System is intended for the dilatation of peripheral vasculature (PTA). This device is not intended for use in the coronary arteries.
- Coil Pusher: The coil pusher is a guidewire-like device consisting of a stainless steel wire with a radiopaque gold marker at its tip. The coil pusher is intended to be used by the physician in deploying the coil to the site.
- Guidewire Introducer: The guidewire introducer consists of a cannula and luer used to introduce guidewires into catheter hubs or hemostatic valves.
- Guidewire Torquer: The guidewire torquer was developed to enhance control of torqueable guidewires during intravascular placement.
- Rotating Hemostatic Valve: To maintain a fluid tight seal at the point of entry when a guiding catheter or sheath is used to support the placement of a therapeutic or diagnostic catheter.
- Shaping Mandrel: The Shaping Mandrel is a stainless steel accessory device used by physicians to form or shape a catheter tip to suit the requirements of a particular case.
- Valve Wire: The Valve Wire is used in conjunction with Stealth balloon dilatation catheters to seal the distal end of the balloon section enabling it to be inflated.
Product codes
74 DQX, 74 GBK, 74 LIT, 74 KRD, 74 DYG, 84 HCG
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
- intracranial
- peripheral vasculature
- neuro vasculature
- coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
treating neurosurgical team
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION:
Table 1 summarizes the testing done in support of a determination of substantial equivalence. Testing in support of this submission may be found in Section 6 beginning on page 37.
| Product Family | Functional Tests | Chemical Degradation / Biocompatibility Tests | Sterile Barrier Test |
|---|---|---|---|
| Guglielmi Detachable Coil (GDC(R)) | • Visual / Dimensional Inspection | ||
| • Detachment Time | |||
| • Bushing Leak Test | |||
| • Tensile Strength | |||
| Reference Section 6E, Page 118 | FTIR spectragraphs generated for: | ||
| • Dacron Fiber | |||
| • PTFE Bushing | |||
| • Teflon Spray | |||
| Reference Section 6E, Page 119 and 125 | Packaging Integrity / Microbial Challenge Test (Tracker-18 used for representative product packaging) | ||
| Reference: Section 6E, Page 119 and Section 6F, Page 130 | |||
| Occlusion Coils | • Visual / Dimensional Inspection | ||
| • Fiber Integrity | |||
| Reference Section 6D, Page 106 | FTIR spectragraph generated for: | ||
| • Dacron Fiber | |||
| Reference Section 6D, Page 107 and 114 | Packaging Integrity / Microbial Challenge Test (Tracker-18 used for representative product packaging) | ||
| Reference: Section 6D, Page 107 and Section 6F, Page 130 | |||
| Tracker Infusion Catheters | • Visual / Dimensional Inspection | ||
| • Tip Flexibility | |||
| • Static Rupture | |||
| • Tensile Strength | |||
| • Coating Integrity | |||
| Reference Section 6B, Page 65 | FTIR spectragraphs generated for: | ||
| • Polyethylene | |||
| • Polyethylene w/ Silicone Coating | |||
| • Silicone Coating | |||
| • Polypropylene | |||
| • Polycarbonate Hub | |||
| • Polyurethane Luer Fitting | |||
| • Polycarbonate RHV | |||
| Reference Section 6B, Page 67 and 76 | Packaging Integrity / Microbial Challenge Test (Tracker-18 used for representative product packaging) | ||
| Reference: Section 6B, Page 67 and Section 6F, Page 130 | |||
| STEALTH Balloon Dilatation Catheters | • Visual / Dimensional Inspection | ||
| • Static Rupture | |||
| • Valve Wire Sealing | |||
| • Silicone Coating Integrity | |||
| Reference Section 6C, Page 90 | FTIR spectragraphs generated for: | ||
| • Silicone Coating | |||
| • Polyethylene - distal shaft - proximal shaft - balloon tubing | |||
| Reference Section 6C, Page 90 and 99 | Packaging Integrity / Microbial Challenge Test (Tracker-18 used for representative product packaging) | ||
| Reference: Section 6C, Page 90 and Section 6F, Page 130 | |||
| Guidewires | • Visual / Dimensional Inspection | ||
| • Tip Stiffness | |||
| • Tensile Strength | |||
| • Turns to Failure | |||
| • Teflon Adhesion - Spray coating - Laminated tubing | |||
| Reference Section 6A, Page 39 | FTIR spectragraphs generated for: | ||
| • Teflon Spray Coating | |||
| • Teflon Tubing, Laminated | |||
| • Silicone Coating | |||
| Reference Section 6A, Page 41 and 59 | Packaging Integrity / Microbial Challenge Test (Tracker-18 used for representative product packaging) | ||
| Reference: Section 6A, Page 41 and Section 6F, Page 130 | |||
| Accessories: Guidewire Torquer | • Visual / Dimensional Inspection | ||
| • Component Compatibility Test | |||
| • Grip Test | |||
| Reference Section 6A, Page 40 | N/A - no body contact | Packaging Integrity / Microbial Challenge Test (Tracker-18 used for representative product packaging) | |
| Section 6F, Page 130 | |||
| Accessories: Guidewire Introducer | • Visual / Dimensional Inspection | ||
| • Introducer Pull Test | |||
| Reference Section 6A, Page 40 | N/A - no body contact | Packaging Integrity / Microbial Challenge Test (Tracker-18 used for representative product packaging) | |
| Section 6F, Page 130 | |||
| Accessories (cont.): Rotating Hemostatic Valve | • Visual / Dimensional Inspection | ||
| Reference Section 6B, Page 84 | FTIR spectrograph generated for: | ||
| • Polycarbonate | |||
| Reference Section 6B, Page 84 and 94 | Packaging Integrity / Microbial Challenge Test (Tracker-18 used for representative product packaging) | ||
| Reference: Section 6F, Page 130 | |||
| Shaping Mandrel | Covered under testing done for guidewires. | ||
| Reference Section 6A, Page 66 | Covered under testing done for guidewires. | ||
| Reference Section 6A. | " | ||
| Valve Wire | Covered under testing done for guidewires. | ||
| Reference Section 6A. | FTIR spectrographs generated for: | ||
| • Teflon coating | |||
| • Silicone coating | |||
| Covered under testing done for guidewires. | |||
| Reference Section 6A. | " | ||
| Coil Pushers | • Visual / Dimensional Inspection | ||
| • Tip Stiffness | |||
| • Tensile Strength | |||
| • Turns to Failure | |||
| • Teflon Adhesion - Spray coating - Laminated tubing | |||
| Reference Section 6A, Page 39 | FTIR spectrograph generated for: | ||
| • Teflon coating | |||
| Covered under testing done for guidewires. | |||
| Reference Section 6A. | " |
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K962503, K950069, K915115, K924987, K880762, K912293, K922912, K955293, K964112, K914786, K925813, K915895, K873971, K873972, K860840, K911779, K891688, K951159, K90428
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1330 Catheter guide wire.
(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.
0
Image /page/0/Picture/0 description: The image shows the logo for Target Therapeutics. The logo consists of a black circle with a horizontal line through the center, followed by the word "TARGET" in large, bold letters. Below "TARGET" is the word "THERAPEUTICS" in smaller letters.
K971395
July 14, 1997
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS, CLASS III CERTIFICATION STATEMENT, CERTIFICATION OF IDENTICAL MATERIALS
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
a) Summary of Safety and Effectiveness
CONTACT PERSON:
Roxane Baxter Manager, Regulatory Affairs Target Therapeutics, Inc. 47201 Lakeview Blvd. Fremont, CA 94538-6530
DEVICE NAMES:
Please refer to Table 1 (Page 10)
DEVICE DESCRIPTIONS:
Please refer to Table 1 (Page 10)
INDICATIONS FOR USE:
Please refer to Table 2 (Pages 13 and 14)
PREDICATE DEVICES:
- · Guglielmi Detachable Coil K962503
- · GUIDEWIRES
- Dasher K950069, K915115
- Taper K924987, K880762
- Seeker K912293, K922912
- Stubbie K912293
- · OCCLUSION COILS
- Fibered Platinum Coil, .035" Type K955293
- Berenstein Liquid Coil K964112
- Occlusion Coils K914786
- · TRACKER Infusion Catheters K925813
- · STEALTH Dilatation Catheters K915895
- · ACCESSORIES
- Rotating Hemostatic Valve K873971
- Guidewire Introducer K873972
- Guidewire Torquer K860840
- Coil Pusher K911779, K891688
- Shaping Mandrel K951159
- Valve Wire K915895, K90428
1
TESTING in SUPPORT of SUBSTANTIAL EQUIVALENCE DETERMINATION:
Table 1 summarizes the testing done in support of a determination of substantial equivalence. Testing in support of this submission may be found in Section 6 beginning on page 37.
| Product Family | Functional
Tests | Chemical Degradation /
Biocompatibility Tests | Sterile Barrier Test |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Guglielmi
Detachable Coil
(GDC®) | • Visual / Dimensional
Inspection
• Detachment Time
• Bushing Leak Test
• Tensile Strength
Reference Section 6E,
Page 118 | FTIR spectragraphs
generated for:
• Dacron Fiber
• PTFE Bushing
• Teflon Spray
Reference Section 6E,
Page 119 and 125 | Packaging Integrity /
Microbial Challenge Test
(Tracker-18 used for
representative product
packaging)
Reference:
Section 6E, Page 119 and
Section 6F, Page 130 |
| Occlusion Coils | • Visual / Dimensional
Inspection
• Fiber Integrity
Reference Section 6D,
Page 106 | FTIR spectragraph
generated for:
• Dacron Fiber
Reference Section 6D,
Page 107 and 114 | Packaging Integrity /
Microbial Challenge Test
(Tracker-18 used for
representative product
packaging)
Reference:
Section 6D, Page 107 and
Section 6F, Page 130 |
| Tracker Infusion
Catheters | • Visual / Dimensional
Inspection
• Tip Flexibility
• Static Rupture
• Tensile Strength
• Coating Integrity
Reference Section 6B,
Page 65 | FTIR spectragraphs
generated for:
• Polyethylene
• Polyethylene w/
Silicone Coating
• Silicone Coating
• Polypropylene
• Polycarbonate Hub
• Polyurethane Luer
Fitting
• Polycarbonate RHV
Reference Section 6B,
Page 67 and 76 | Packaging Integrity /
Microbial Challenge Test
(Tracker-18 used for
representative product
packaging)
Reference:
Section 6B, Page 67 and
Section 6F, Page 130 |
| Table 1 |
|---|
| Summary of Tests - By Product or Product Family |
Image /page/1/Picture/6 description: The image contains a handwritten text "SD" in a simple, cursive style. The letters are large and take up most of the frame. The letter "S" is on the left and the letter "D" is on the right.
2
Table 1 (cont.) Summary of Tests - By Product or Product Family
| Product Family | Functional
Tests | Chemical Degradation /
Biocompatibility Tests | Sterile Barrier Test |
|-----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| STEALTH Balloon
Dilatation Catheters | • Visual / Dimensional
Inspection
• Static Rupture
• Valve Wire Sealing
• Silicone Coating
Integrity
Reference Section 6C,
Page 90 | FTIR spectragraphs
generated for:
• Silicone Coating
• Polyethylene
- distal shaft
- proximal shaft
- balloon tubing
Reference Section 6C,
Page 90 and 99 | Packaging Integrity /
Microbial Challenge Test
(Tracker-18 used for
representative product
packaging)
Reference:
Section 6C, Page 90 and
Section 6F, Page 130 |
| Guidewires | • Visual / Dimensional
Inspection
• Tip Stiffness
• Tensile Strength
• Turns to Failure
• Teflon Adhesion - Spray coating
- Laminated tubing
Reference Section 6A,
Page 39 | FTIR spectragraphs
generated for:
• Teflon Spray Coating
• Teflon Tubing,
Laminated
• Silicone Coating
Reference Section 6A,
Page 41 and 59 | Packaging Integrity /
Microbial Challenge Test
(Tracker-18 used for
representative product
packaging)
Reference:
Section 6A, Page 41 and
Section 6F, Page 130 |
| Accessories | | | |
| Guidewire Torquer | • Visual / Dimensional
Inspection
• Component
Compatibility Test
• Grip Test
Reference Section 6A,
Page 40 | N/A - no body contact | Packaging Integrity /
Microbial Challenge Test
(Tracker-18 used for
representative product
packaging)
Section 6F, Page 130 |
| Guidewire Introducer | • Visual / Dimensional
Inspection
• Introducer Pull Test
Reference Section 6A,
Page 40 | N/A - no body contact | Packaging Integrity /
Microbial Challenge Test
(Tracker-18 used for
representative product
packaging)
Section 6F, Page 130 |
| Product Family | Functional
Tests | Chemical Degradation /
Biocompatibility Tests | Sterile Barrier Test |
| Accessories (cont.)
Rotating Hemostatic
Valve | • Visual / Dimensional
Inspection
Reference Section 6B,
Page 84 | FTIR spectrograph
generated for:
• Polycarbonate
Reference Section 6B,
Page 84 and 94 | Packaging Integrity /
Microbial Challenge Test
(Tracker-18 used for
representative product
packaging)
Reference:
Section 6F, Page 130 |
| Shaping Mandrel | Covered under testing
done for guidewires.
Reference Section 6A,
Page 66 | Covered under testing
done for guidewires.
Reference Section 6A. | " |
| Valve Wire | Covered under testing
done for guidewires.
Reference Section 6A. | FTIR spectrographs
generated for:
• Teflon coating
• Silicone coating
Covered under testing
done for guidewires.
Reference Section 6A. | " |
| Coil Pushers | • Visual / Dimensional
Inspection
• Tip Stiffness
• Tensile Strength
• Turns to Failure
• Teflon Adhesion
- Spray coating
- Laminated tubing
Reference Section 6A,
Page 39 | FTIR spectrograph
generated for:
• Teflon coating
Covered under testing
done for guidewires.
Reference Section 6A. | " |
Image /page/2/Picture/4 description: The image contains a simple, hand-drawn letter 'S'. The 'S' is slightly tilted to the left and has a somewhat irregular shape, suggesting it was drawn quickly or without precise attention to detail. The lines forming the 'S' are thick and dark, providing a clear contrast against the white background.
3
Table 1 (cont.) Summary of Tests - By Product or Product Family
Image /page/3/Picture/4 description: The image shows a signature. The signature is illegible and appears to be written in cursive. The signature is black and is on a white background.
4
Image /page/4/Picture/2 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The image is in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Roxane Baxter Manager, Regulatory affairs Target Therapeutics 47201 Lakeview Boulevard Fremont, California 94538-6530
JUL 14 1997
K971395 Re: Various Class II and Class III devices (add shelf life) Requlatory Class: II and III (Two and Three) Product Codes: 74 DQX, 74 GBK, 74 LIT, 74 KRD, 74 DYG, and 84 HCG Dated: April 14, 1997 Received: April 15, 1997
Dear Ms. Baxter:
We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Fractice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act
Image /page/4/Picture/10 description: The image shows a black and white abstract design. The design features a circular shape that is partially filled with black ink or paint. The left side of the circle has some vertical lines, while the right side is mostly filled with a solid black color.
5
Page 2 - Ms. Roxane Baxter
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification (i.e., with a shelf life of either 36 or 50 months, depending on the device). The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other qeneral information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/5/Picture/7 description: The image shows a black and white abstract design. The design appears to be a partial circle or sphere. The left side of the shape has a textured, brush-stroke appearance, while the right side is a solid, dark area with some irregular edges.
6
Page_1__of_1
TARGET THELAPEUTIC
510(k) Number (if known): K971395 Device Name: See table below
Indications For Use: See table below
| Device Name | Indications |
|---|---|
| Guglielmi Detachable Coils (GDC®) | For embolizing certain intracranial aneurysms that - because of their morphology, their location, or the |
| patient's general medical condition - are considered by the treating neurosurgical team to be a) very high | |
| risk for management by traditional operative techniques, or b) inoperable; and for embolizing other | |
| vascular malformation such as arteriovenous malformations and arteriovenous fistulae of the neuro | |
| vasculature. The GDC is also intended for arterial and venous embolizations in the peripheral | |
| vasculature. | |
| Occlusion Coils: | |
| Fibered Platinum Coil, .035" Type | For arterial and venous embolizations in the peripheral vasculature |
| Berenstein Liquid Coil | For the embolization of vascular malformations of the peripheral, coronary and neuro vasculature. |
| Occlusion Coils (except Fibered | |
| Platinum Coil .035" Type and | |
| Berenstein Liquid Coil) | Coils are intended to obstruct or reduce blood flow in the peripheral and neurovasculature. They are |
| intended for use in the interventional radiologic management of arteriovenous malformations and | |
| arteriovenous fistulas when devascularization prior to definitive surgical resection is desirable. | |
| Guidewires | Target Therapeutics Steerable Guidewires are designed to assist in the delivery of Tracker Infusion |
| Catheters to selected vascular sites. | |
| Tracker® Infusion Catheter | Tracker Infusion Catheters are designed to assist in the delivery of diagnostic agents, such as contrast |
| media, and therapeutic agents, such as occlusion coils, into the peripheral, coronary, and | |
| neurovasculature. | |
| Stealth® Dilation Catheter | The Stealth Dilation Catheter System is intended for the dilatation of peripheral vasculature (PTA). This |
| device is not intended for use in the coronary arteries. | |
| Coil Pusher | The coil pusher is a guidewire-like device consisting of a stainless steel wire with a radiopaque gold |
| marker at its tip. The coil pusher is intended to be used by the physician in deploying the coil to the site. | |
| Guidewire Introducer | The guidewire introducer consists of a cannula and luer used to introduce guidewires into catheter hubs |
| or hemostatic valves. | |
| Guidewire Torquer | The guidewire torquer was developed to enhance control of torqueable guidewires during intravascular |
| placement. | |
| Rotating Hemostatic Valve | To maintain a fluid tight seal at the point of entry when a guiding catheter or sheath is used to support the |
| placement of a therapeutic or diagnostic catheter. | |
| Shaping Mandrel | The Shaping Mandrel is a stainless steel accessory device used by physicians to form or shape a |
| catheter tip to suit the requirements of a particular case. | |
| Valve Wire | The Valve Wire is used in conjunction with Stealth balloon dilatation catheters to seal the distal end of the |
| balloon section enabling it to be inflated. |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
_
(Division Sign-Off)
Division of Cardiovascular. Respiratory, and Neurological Devices
510(k) Number_k 471395
Prescription Use X (Per 21 CFR 801.109) OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)