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Found 506 results
510(k) Data Aggregation
(28 days)
95131
Re: K260130
Trade/Device Name: Willow 18 Guidewire
Regulation Number: 21 CFR 870.1330
Guidewire
Common Name: Wire, Guide, Catheter
Classification Name: Wire, Guide, Catheter, 21 CFR 870.1330
Willow 18 Guidewire (K260130) |
|---|---|---|
| Classification Name | Wire, Guide, Catheter, 21 CFR 870.1330
The Willow 18 Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Like the predicate device, the Willow 18 Guidewire is a single-use product with a shapeable tip, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The Willow 18 Guidewire comes in two stiffness profiles: Soft and Standard.
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(220 days)
California 92614
Re: K252011
Trade/Device Name: CHIKAI Nexus petit
Regulation Number: 21 CFR 870.1330
asahi-intecc-us.com
Device Name: CHIKAI Nexus petit
Device Classification: Class II, 21 CFR § 870.1330
LTD. | Balt USA, LLC. | Abbott Vascular | Micro Therapeutics, Inc. |
| Regulation Number | 21 CFR 870.1330
This guide wire is intended to be used in the neuro vasculature to facilitate the placement and exchange of therapeutic devices such as cerebral catheters during intravascular therapy. This guide wire is intended for use only in the neuro vasculature.
The basic structure of the CHIKAI Nexus petit consists of a hybrid tapered core wire in which Ni-Ti alloy and stainless steel (SUS) is conjoined via Ni-Ti pipe. The distal part of the core wire is surrounded by the Pt-Ni (platinum-nickel) coil, soldered with Au-Sn (gold-tin) alloy. For the proximal coil, the joint section is covered by a tube made of Ni-Ti alloy. Within the tube, the stainless steel and Ni-Ti core wires are connected with ASAHI's proprietary stainless-steel coil, soldered with Au-Sn alloy and silver.
In addition, coatings are applied on the surface of the device. The distal coil section is coated with a polyurethane coating. The hydrophilic coating is applied from the distal tip, on top of the polyurethane coating, to the proximal shaft.
The maximum nominal outer diameter of the CHIKAI Nexus petit is 0.33 mm (0.013"). The diameter is tapered towards the distal tip with the nominal diameter of 0.16mm (0.006"). The CHIKAI Nexus petit's radiopaque distal tip (up to 8cm from the tip) enables the user to view the position of the tip under X-ray fluoroscopy.
The device is available in length of 220cm with tip-shape variations of Straight, Round-curve and J-shape design.
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(60 days)
Trade/Device Name:** Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
Regulation Number: 21 CFR 870.1330
Trade/Device Name:** Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
The Splashwire Hydrophilic Guide Wire is intended to be used in the peripheral vascular system to facilitate the placement of devices during diagnostic and interventional procedures.
The Splashwire Hydrophilic guide wire consists of a nitinol core wire with a ground tapered distal section. A polyurethane jacket which contains tungsten for radiopacity is applied over the core wire and a hydrophilic coating is applied over the polyurethane jacket. The surface of the jacket is uniform with both the distal and proximal ends fully coated. The wire is placed inside a multiple loop flush dispenser, also referred to as a hoop. The dispenser has a flush port which facilitates solution flushing through the hoop to hydrate the guide wire. The wire is placed so that the distal end of the wire comes out of the outer portion of the hoop. A J-straightener is placed on the other end of the hoop to introduce the wire into the catheter. The wire is sold sterile and is a single use device. The subject Splashwire Hydrophilic Guide Wire Line Extensions and the predicate Splashwire Hydrophilic Guide Wire share the device characteristics described above, with the subject guide wire incorporating the following additional modifications:
J-Tip Guide Wires:
The J Tip devices incorporate a distal tip formed into a J shape. These guide wires are provided with a 3.0 mm J Tip.
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(261 days)
: K251385**
Trade/Device Name: InQwire Super Stiff Guide Wire
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
Product code:** DQX
Classification Name: Wire, Guide, Catheter
Regulation Number: 21 CFR 870.1330
The InQwire Super Stiff Guide Wire is intended to facilitate the placement of devices during diagnostic and interventional procedures. The InQwire Super Stiff Guide Wire is indicated for use in the peripheral vasculature and chambers of the heart, excluding the coronary arteries and cerebral vasculature.
The Merit InQwire Super Stiff guide wire consists of 0.032" and 0.035" outer diameter (OD) guidewire configurations with guidewire lengths of 80cm, 100cm, 150cm, 180cm and 260cm. The guidewire is provided in straight and J3mm with a range of flexible properties.
The Merit InQwire Super Stiff guide wire is composed of a stainless-steel core wire and a PTFE coated stainless steel coil. The guidewire is welded at the distal and proximal tip with each tip having a polished weld finish. The stainless-steel construction provides radiopacity. The guidewire is supplied sterile, non-pyrogenic and is intended for single patient use only.
The Merit InQwire Super Stiff guide wire is placed through a vascular access device and advanced under fluoroscopy to the desired location according to the planned procedure by the clinician. It is used to facilitate the placement of devices during diagnostic and interventional procedures within the peripheral vasculature and central circulatory system, excluding the coronary arteries and cerebral vasculature.
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(137 days)
K252674**
Trade/Device Name: Solo Pace Fusion System (SOLOFUSE1)
Regulation Number: 21 CFR 870.1330
K252674**
Trade/Device Name: Solo Pace Fusion System (SOLOFUSE1)
Regulation Number: 21 CFR 870.1330
System |
|---|---|
| Common / Usual Name | Catheter Guidewire |
| Classification Name | 21 CFR 870.1330
System |
|---|---|
| Common / Usual Name | Catheter Guidewire |
| Classification Name | 21 CFR 870.1330
Solo Pace Fusion is intended for use to introduce and position interventional devices within the chambers of the heart, including those used for transcatheter aortic valve procedures. Solo Pace Fusion can be used for temporary intracardiac pacing by transmitting an electrical signal from Solo Pace Control to the heart.
The Solo Pace Fusion System consists of the following components:
- Fusion Guidewire
- Fusion Ground Pad
- Fusion Connection Cable
- Solo Pace Control System, consisting of the following:
- Solo Pace Remote Control Module (RCM), packaged with the Fusion Guidewire, Fusion Ground Pad and Fusion Connection Cable
- Solo Pace External Pulse Generator (EPG) (sold separately)
The Fusion Guidewire is intended to deliver interventional devices into the heart and serve as the pacing conduit when used with the Solo Pace Control system. The Fusion Guidewire is made of stainless steel and includes a pre-shaped pigtail distal tip. The Fusion Guidewire has a diameter of 0.035" (0.89 mm) and a length of 275 cm. The Fusion Guidewire is supplied with a tip insertion tube to help advance the guidewire into a catheter. A PTFE coating covers the shaft for lubricity. The proximal 8mm is uncoated to allow connection of the Fusion Guidewire to the Fusion Connection Cable. The pigtail is coated with silicone for lubricity. The Fusion Guidewire is supplied sterile, non-pyrogenic and is intended for single use only.
The Fusion Ground Pad is a transcutaneous pad placed on the patient to serve as the anode terminal for unipolar pacing via a unique connection to the Fusion Connection Cable. The Ground Pad acts as the return electrode for the pacing signal delivered to the patient's heart through the Fusion Guidewire. The Ground Pad cable is 60 inches (1.5 m) long and the skin contacting surface area is 350 cm².
The Fusion Connection Cable connects the Fusion Guidewire and the Fusion Ground Pad to the Solo Pace Control System (EPG component) in a manner that ensures proper polarity. The Fusion Connection Cable is approximately 60 inches (1.5 m) long.
The Solo Pace Control System RCM is a single use sterile device supplied with the Solo Pace Fusion System. The Solo Pace RCM connects wirelessly with the EPG to allow physician control of the EPG in the sterile field.
The Solo Pace Control System EPG is a reusable, external pulse generator described in detail in its Instructions for Use (IFU). The Solo Pace Control IFU should be reviewed, in its entirety, prior to the use of the Solo Pace Fusion System. Solo Pace Control was cleared for use under K241781.
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(61 days)
95131
Re: K253168
Trade/Device Name: 0.014" Willow Guidewire
Regulation Number: 21 CFR 870.1330
Guidewire
Common Name: Wire, Guide, Catheter
Classification Name: Wire, Guide, Catheter, 21 CFR 870.1330
Guidewire
Common Name: Wire, Guide, Catheter
Classification Name: Wire, Guide, Catheter, 21 CFR 870.1330
0.014" Willow Guidewire (K253168) |
|---|---|---|
| Classification Name | Wire, Guide, Catheter, 21 CFR 870.1330
The 0.014" Willow Guidewire is intended for general intravascular use, including neurovascular and peripheral vasculatures. It can be used to selectively introduce and position catheters and other interventional devices within the peripheral and neuro vasculature. This device should be used only by physicians trained in percutaneous, intravascular techniques and procedures.
Like the predicate device, the 0.014" Willow Guidewire is a single-use product with a shapeable tip available in straight and pre-shaped configurations, used to gain intravascular access to facilitate the positioning and exchange of interventional devices in small diameter, tortuous vasculature for neuro and peripheral diagnostic and interventional procedures. The wire can be torqued to facilitate navigation through the vasculature. The 0.014" Willow Guidewire comes in three stiffness profiles: Soft, Standard and Support.
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(166 days)
K251596**
Trade/Device Name: Lunderquist Extra Stiff Wire Guide
Regulation Number: 21 CFR 870.1330
Common Name: Guidewire
Classification Name: Catheter guide wire
Regulation: 21 CFR 870.1330
The Lunderquist Extra Stiff Wire Guides are intended to facilitate catheterization and/or placement of devices during vascular interventional procedures.
The Lunderquist Extra Stiff Wire Guides are intended for use in the aorta, including its access vessels and major adjacent vessels.
The Lunderquist Extra Stiff Wire Guides are auxiliary devices and hence not primary interventional devices themselves. Instead, they are intended to facilitate vascular access and/or delivery of over-the-wire medical devices during endovascular procedures, including TEVAR/EVAR procedures.
The Lunderquist Extra Stiff Wire Guides are both long and stiff; features that make them suitable for facilitating endovascular procedures that involve placement of large devices e.g., stent grafts in the aorta. The wire guides are not intended for coronary or neurovascular use.
The Lunderquist® Extra Stiff Wire Guides are 0.035 inch PTFE coated stainless steel wire guides consisting of a mandril and a 15 cm or 18 cm long coil. The mandril has a tapered end with a length of 11 cm and an additional 4 or 7 cm flexible tip. The Lunderquist wire guides are available in the following configurations:
Straight Lunderquist wire guides (TSMG-/-LES) are available in lengths of 90, 145, 180, 260, and 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil.
Curved Lunderquist wire guides (TSCMG-/-LES) are available in lengths of 90, 145, 180, 260, and 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil. The J-curve radius for the curved wire guides is either 3 mm or 7 mm.
Double Curved Lunderquist wire guides (TSCMG-/-LESDC) are available in lengths of 260 and 300 cm with a 4 cm flexible tip that includes an inner gold coil. The Double Curved Lunderquist wire guides have a large curve/J-curve radius of 75/15 mm.
Extended Double Curved Lunderquist wire guides (TSCMG-/-E-LESDC) are available in lengths of 260 and 300 cm with a 4 cm flexible tip that includes an inner gold coil. The Extended Double Curved Lunderquist wire guides have an extended large curve/J-curve radius of 55/15 mm.
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(64 days)
LumiGuide Wire
Classification Name: Catheter guide wire
Classification Regulation: 21 CFR, Part 870.1330
Page 6
Classification Name: Catheter guide wire
Classification Regulation: 21 CFR, Part 870.1330
The LumiGuide Equipment is a visualization device with Fiber Optic RealShape (FORS) technology intended to aid the positioning and navigation of a connected LumiGuide Wire and, optionally, a catheter during endovascular procedures of the peripheral, aortic and aortic side branch vasculature, by creating a 3D image in real-time of the connected LumiGuide Wire and, of an endovascular catheter, when combined with a LumiGuide 3D Hub.
The LumiGuide Wire is an angiographic guidewire with Fiber Optic RealShape (FORS) technology, intended to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature.
The LumiGuide 3D Hub enables the visualization of a connected endovascular catheter, when used in combination with a LumiGuide Wire and the LumiGuide Equipment.
The LumiGuide system consists of the following primary devices:
The LumiGuide Equipment R2.1 is a visualization device with Fiber Optic RealShape (FORS) technology. Its function is to create a real time 3D image of a LumiGuide Wire and, optionally, an endovascular catheter when combined with LumiGuide 3D Hub, and overlay this on real time or pre-recorded X-ray images and/or on a pre-operative CT volume. The LumiGuide Equipment R2.1 comprises software and hardware components (such as lasers, optical components, computer hardware, electrical and optical cabling), and a single-use, sterile, detachable component.
The LumiGuide Wire is a sterile, single use, angiographic guidewire with Fiber Optic RealShape (FORS) technology that is available in two configurations: LumiGuide Navigation Wire 3D Ultra and LumiGuide Navigation Wire 3D Plus. The primary function of the LumiGuide Wire is to direct a catheter in endovascular procedures of the peripheral, aortic and aortic side branch vasculature. The LumiGuide Wire can be visualized in 3D in real time by the LumiGuide Equipment R2.1 using FORS technology.
The LumiGuide 3D Hub is a sterile, single use accessory to the LumiGuide Equipment R2.1 that connects to the luer connector of endovascular catheters. When the LumiGuide Hub is connected to an endovascular catheter and is used in combination with a LumiGuide Wire, the LumiGuide Equipment R2.1 enables real time 3D visualization of the connected endovascular catheter.
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(266 days)
27541
Re: K250203
Trade/Device Name: SureAx-Guide™ Guidewire
Regulation Number: 21 CFR 870.1330
Catheter guide wire
Regulatory Class: Class II
Product Code and Regulation: DQX, 21 CFR 870.1330
Approach Hydro ST Guidewire | N/A |
| Product Code | DQX | DQX | Same |
| Regulation Number | 21 CFR 870.1330
| 21 CFR 870.1330 | Same |
| Regulatory Class | II | II | Same |
| Nominal Wire Outer Diameter | 0.014
The SureAx-Guide guidewire is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature. The SureAx-Guide guidewire is not intended for use in the coronary or neuro vasculature.
The SureAx-Guide™ guidewire is comprised of a stainless-steel wire with a PTFE coating and distal coils and soldered tip. The distal end has a urethane sheath and PVP-based hydrophilic coating. The maximum outside diameter is 0.0142 inches and it will be available in 135cm and 190cm lengths. It will be supplied sterile and intended for single use.
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(269 days)
Re: K250031/S001
Trade/Device Name: Amplatzer Guidewire
Regulation Number: 21 CFR 870.1330
Re: K250031/S001
Trade/Device Name: Amplatzer Guidewire
Regulation Number: 21 CFR 870.1330
Catheter Guide Wire
Device Class: Class II
Product Code: DQX
Product Regulation: 21 CFR 870.1330
The Amplatzer™ Guidewire is intended to facilitate the introduction and exchange of a delivery system or catheter within the vasculature and chambers of the heart.
The Amplatzer™ Guidewire is 0.035-inch in diameter and made of a stainless steel core and a full length stainless steel spring coil coated with low-friction polytetrafluoroethylene (PTFE). The stainless steel core extends to the distal tip of the guidewire for one model (9-GW-001). Two models (9-GW-002 and 9-GW-003) have a stainless steel core that does not extend to the distal end of the wire. These models have an additional ribbon wire that runs parallel to the stainless steel core and extends to the distal end of the guidewire. The stainless steel core for all three models is tapered at the distal end of the guidewire to provide a smooth transition to the distal floppy segment.
The guidewires are available in two working lengths, 260 cm (9-GW-001 and 9‑GW‑002) and 300 cm (9-GW-003). The distal tip of the guidewire is available in two designs: a Modified J-Tip (9-GW-001) and a J-Tip (9-GW-002 and 9-GW-003). The J-straightener can be used to straighten the distal tip for all models. Model 9-GW-003 can also be manually straightened. The guidewire is sterile and for single use only.
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