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K Number
K220981Device Name
SUPERPLAST Double-Occluder, SUPERPLAST Vascular Probe
Manufacturer
Fehling Surgical Instruments, Inc.
Date Cleared
2023-04-20
(381 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
Device Description
The Fehling SUPERPLAST Probes are intended to be used to enlarge or calibrate vessels during coronary artery bypass and angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels and to perform various maneuvers of dilation and measurement of annulus and lumen diameters. The coronary probe is available in different lengths and diameters to accommodate the needs of various surgical procedures and vessel anatomies. The probe is constructed of Titanium Alloy (TiAl6V4), Nitinol, and Titanium (Grade 2). Coronary probes are supplied non-sterile.
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K Number
K183438Device Name
Geomed Vascular Dilators
Manufacturer
Geomed Medizin-Technik GmbH & Co.
Date Cleared
2019-09-03
(265 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Geomed Vascular Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
Device Description
Vascular Dilators are reusable stainless-steel surgical instruments that are used by qualified surgeons to enlarge or calibrate vessels. They are provided in two basic models and various sizes to accommodate individual needs, based on the anatomy of the site and the type of surgical procedure. The device is provided non-sterile for steam sterilization by the user.
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K Number
K163524Device Name
Vessel Dilator
Manufacturer
Fetzer Medical GmbH & Co. KG
Date Cleared
2017-06-29
(196 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Fetzer Medical vessel dilators are devices used to enlarge or calibrate a vessel during cardiovascular surgery.
Device Description
Fetzer Medical Vessel Dilators are reusable manual surgical instruments. They are rod-like devices with a long, slender, solid shaft and a distal tip of various shapes and sizes. They are sold unsterile and can be reused (cleaned and sterilized) according the instructions for use.
There are several types of dilators made from stainless steel or aluminum:
- Cooley Coronary Dilators
- Cooley Vessel Dilators
- Garrett Vascular Dilators
- Hiebert Vascular Dilators
- DeBakey Vascular Dilators
- Sarns-Style Dilators
- Myocardial Dilators
These dilators are available in a range of different length and diameters.
The handle of the DeBakey Vascular Dilator, the Cooley Vessel Dilator, the Cooley Coronary Dilator, the Hiebert Vascular Dilator and the Garrett Vascular Dilator is textured with one site flat. The handles of the Sarns and Myocardial Dilators are smooth. The Myocardial Dilator has a flat distal end for holding it and the Sarns Dilator has a hollow handle at the distal end.
Apart from the Hiebert Vascular Dilator and the Myocardial Dilator, the handle is connected to a thin shaft. The diameter of the shaft of the different dilator types varies. The shaft of the Cooley Coronary Dilator, the Cooley Vessel Dilator, The Garrett Vascular Dilator and the DeBakey Vascular Dilator can be thin so that the shaft is flexible. The handle of the Myocardial Dilator has no shaft while the Hiebert Vascular Dilator is double-ended; it possesses two flexible shafts, with the handle located in between the two thin shafts.
The tips of all dilators have the aim to enlarge a vessel. The design of the Sarns and Myocardial Dilator is similar to an elephant's tusk. The diameter increases steadily, moving towards the handle's direction. The tips of the other Dilators are olive-shaped. The Cooley Coronary Dilator possesses no formed tip. For all dilators, the penetrating diameter corresponds to the diameter of the shaft. The Hiebert Vascular Dilators working elements are each malleable wires with an olive tip in different diameters.
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K Number
K130896Device Name
VASCULAR PROBE, VASCULAR PROBE ES
Manufacturer
SYNOVIS LIFE TECHNOLOGIES, INC.
Date Cleared
2013-04-24
(23 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The disposable Vascular Probe is intended to be used during coronary and peripheral vascular surgery to probe blood vessels distally and proximally for blockages, to measure the internal diameter of vessels, and to act as an intravascular retractor.
Device Description
The Vascular Probe is a sterile, single use, disposable device with a polyurethane coated streamline bulb on each end of a flexible polycarbonate or polycarbonate-polyurethane shaft. The bulbs are of different size on each end of the Vascular Probe. An appropriately-sized bulb is inserted either proximally or distally through the arteriotomy to probe the interior of the vessel and may be used by the surgeon to retract the vascular wall.
The Vascular Probe is packaged in a double sterile barrier. The contents of the unopened, undamaged container are sterile.
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K Number
K100518Device Name
INSTRUMED VESSEL DILATORS, MODEL 65-7XX,65-9XXX,66-1XXX,65-7048-65-7054
Manufacturer
INSTRUMED INTERNATIONAL, INC.
Date Cleared
2010-08-31
(189 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
INSTRUMED Vessel Dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various manoeuvres of dilation and measurement of annulus and lumen diameters.
Device Description
Instrumed Vessel Dilators are reusable surgical instruments. To ensure the multi-purpose use of this device, different models are available. The differences can be in length, diameter, and design of the dilators. Dilators are used to check patency of vessel in coronary artery bypass procedures, to check patency of other vessels in pheripheral vascular procedures, olive shaped tips (Garrett). The surgeon chooses the instrument based on the anatomy of the vessel and the type desired, and on the type of the surgical procedure. Instrumed Vessel Dilators are made of ASTM F 899-07 standardized Stainless Steel. The instruments are offered in non-sterile condition.
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K Number
K051817Device Name
BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM
Manufacturer
CARDIVA MEDICAL, INC.
Date Cleared
2006-12-06
(519 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardiva Medical Boomerang™ Wire System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire System is indicated for use in patients undergoing diagnostic and/or interventional femoral artery catheterization procedures, using 5, 6 or 7 Fr introducer sheaths.
Device Description
The Boomerang™ Wire System consists of a sterile disposable Boomerang Wire and a sterile disposable Boomerang Clip. In conjunction with manual compression, the Boomerang Wire System provides hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Wire is deployed, which open the flat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Wire and the low-profile Boomerang Disc is positioned against the inside of the arteriotomy. Gentle upward tension is applied to the Boomerang Wire, which conforms the Boomerang Disc to the contours of the vessel and secures it against the intima, sealing the arteriotomy. The tension is then held in place by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Wire is completely removed for the artery. No part of the device is left behind nor is there any material introduced to alter the body's own natural clotting process. Final closure of the vessel occurs with manual compression to close the remaining needle puncture site left by removing the Boomerang Wire.
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K Number
K061075Device Name
BOOMERANG WIRE
Manufacturer
CARDIVA MEDICAL, INC.
Date Cleared
2006-09-01
(137 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardiva Medical Boomerang™ Wire is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The Boomerang™ Wire is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.
Device Description
The Boomerang™ Wire consists of a sterile disposable Boomerang Wire and a sterile disposable Boomerang Clip (refer to the detailed Figures 1,2,3 in Section VIII). In conjunction with manual compression, the Boomerang Wire provides hemostasis at a femoral access site after femoral arterial catheterization while allowing continued distal perfusion. After completion of catheterization, the Boomerang Wire is inserted into the artery through the existing introducer sheath. After insertion, the distal tip of the Boomerang Wire is deployed, which opens the ffat, low-profile Boomerang Disc within the lumen of the femoral artery. The Boomerang Disc is then pulled back gently to the distal end of the introducer sheath. The introducer sheath is then removed from the vessel over the Boomerang Wire and the low-profile Boomerang Disc is positioned against the inside of the arteriotomy. Gentle upward tension is applied to the Boomerang Wire, which conforms the Boomerang Disc to the contours of the vessel and secures it against the intima, sealing the arteriotomy. The tension is then held in place by the external Boomerang Clip at the surface of the skin at the puncture site. The tension between the Boomerang Disc and the Boomerang Clip creates a site-specific compression of the arteriotomy and tract and establishes temporary hemostasis. This allows natural recoil of the smooth muscle of the vessel wall to occur at the arteriotomy site while the body's natural clotting process begins. Following the procedure, the Boomerang Disc is collapsed and the Boomerang Wire is completely removed from the artery. No part of the device is left behind nor is there any material introduced to alter the body's own natural clotting process. Final closure of the vessel occurs with manual compression to close the remaining needle puncture site left by removing the Boomerang Wire.
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K Number
K041486Device Name
VASOSTASIS VASCULAR CLOSURE SYSTEM
Manufacturer
CARDIVA MEDICAL, INC.
Date Cleared
2004-10-22
(140 days)
Product Code
DXC
Regulation Number
870.4450Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Cardiva Medical VasoStasis™ Vascular Closure System is intended to promote hemostasis at arteriotomy sites as an adjunct to manual compression. The VasoStasis Vascular Closure System is indicated for use in patients undergoing diagnostic femoral artery catheterization procedures, using 5 or 6 Fr introducer sheaths.
Device Description
The VasoStasis Vascular Closure System consists of the following components: (1) a sterile. disposable catheter (VasoStasis™ VCS Catheter), and (2) a sterile, disposable tensioning device (VasoStasis™ VCS Tensioner). The VasoStasis Vascular Closure System, in conjunction with manual compression, provides hemostasis at femoral access sites after femoral arterial catheterization while allowing continued perfusion of the lower extremities. The VasoStasis VCS Catheter is a single lumen, low profile catheter with an elastomeric membrane at the distal tip. The membrane is covered by a tip guide, which protects the membrane as the cledeployed catheter is inserted into the artery through a previously placed introducer sheath. A small loon handle is at the proximal end of the device and moves axially to deploy or de-deploy a Nitinol coil within the membrane. Once the catheter is introduced into the vessel, the membrane is positioned distal to the introducer sheath and deployed by pushing the loop handle forward. In its fully deployed state, the membrane nominally achieves 13 F in diameter. The Cardiva VasoStasis VCS Tensioner clips on the VasoStasis VCS Catheter shaft on the surface of the skin at the entrance to the arteriotomy and holds the catheter secure while the membrane is deployed in the vessel.
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K Number
K030788Device Name
KAMAR ANNULUS DILATOR + SIZER; GARRETT, COOLEY, AND DEBAKEY VESSEL DILATORS
Manufacturer
GEISTER MEDIZINTECHNIK GMBH
Date Cleared
2003-07-12
(122 days)
Product Code
DWP
Regulation Number
870.4475Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GEISTER vessel dilators are devices used to enlarge or calibrate vessels during coronary artery bypass or angioplasty procedures. They are designed to locate orifices, to trace the course of abnormal vessels, and to perform various maneuvers of dilation and measurement of annulus and lumen diameters.
Device Description
GEISTER vessel dilators
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K Number
K983830Device Name
COPPERHEAD 5 FR. PTA CATHETER, FINCH 4 FR. PTA CATHETER
Manufacturer
MALLINCKROOT, INC.
Date Cleared
1999-04-16
(168 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
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AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Mallinckrodt Peripheral Dilatation Catheter is intended for use in Percutaneous Transluminal Angioplasty (PTA) of the peripheral vasculature system, such as the renal, iliac, femoral, popliteal, peroneal, and profunda arteries.
Device Description
The Mallinckrodt PTA Catheter is intended for single patient use and is disposable, sterile and non-pyrogenic. This dilatation catheter is a coaxial double lumen catheter with a balloon mounted near the distal tip. The balloon is designed to inflate to a known diameter and length at pressures stated on the label (nominal inflation). The outer lumen is used for inflation of the balloon while the inner lumen permits (1) the use of a guide wire to facilitate catheter advancement to and through the stenosis to be dilated, and (2) low flow administration of contrast media to aid in correct positioning of the balloon. The lumens bifurcate from the catheter shaft to two molded hubs (proximal end of catheter), one for the inflation lumen and one for the guide wire lumen. The hubs are labeled for easy identification. The bifurcation is supported by a strain relief sleeve at the catheter end. Two radiopaque markers, within the balloon segment of the catheter, delineate the working length of the balloon for proper balloon orientation within a stenosis. The catheter tip is a highly radiopaque, soft, atraumatic material.
The Mallinckrodt PTA Catheter is available in two shaft diameters (4 and 5 Fr) and several shaft lengths (4 Fr - 90, 135 cm and S Fr - 45, 75, 125 cm). The catheter has a range of balloon sizes from 3 mm to 12 mm in inflated diameter and from 2 to 10 cm in length. (Note: Neither the 4 nor 5 Fr catheter with 12 min balloon is available in 8 and 10 cm length.) The catheters will be available with or without a hydrophilic coating.
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