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510(k) Data Aggregation
K Number
K973013Device Name
OPTI-PLAST (CENTURION) 5.5F ANGIOPLASTY CATHETER
Manufacturer
VAS-CATH, INC.
Date Cleared
1998-06-19
(310 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
VAS-CATH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Centurion Peripheral Balloon Dilatation Catheters are recommended for use in Percutaneous Transluminal Angioplasty of the femoral, iliac and renal arteries, post-deployment dilatation of peripheral vascular stents and for the treatment of obstructive lesions of native or synthetic arteriovenous dialysis fistulae. The catheter is not for use in coronary arteries.
Device Description
The Opti-Plast Centurion 5.5F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accommodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheter is designed to be used in conjunction with a 0.035" diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labeled diameter and length at a 10 atmosphere Operating Pressure. The Rated Burst Pressure of the device ranges from 17-20 atmospheres, depending on balloon diameter (see attached table).
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K Number
K965178Device Name
NIAGARA DUAL LUMEN CATHETER
Manufacturer
VAS-CATH, INC.
Date Cleared
1997-08-19
(238 days)
Product Code
MPB
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
VAS-CATH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Niagara™ Dual Lumen Catheter is indicated for use in attaining short term vascular access for hemodialysis, hemoperfusion, or apheresis therapy via the jugular, subclavian or femoral vein.
Device Description
The Vas-Cath Niagara™ catheter is a polyurethane catheter which allows for dialysis, hemoperfusion or apheresis. The Niagara™ catheter contains two clear polyurethane clamping extensions with luer connectors at the ends and atraumatic nylon clamps. The arterial and venous extensions are identified with red and blue luer connectors. The two extensions merge into a tapered bifurcation joint or hub molded to the catheter body tubing. Both a fixed and a removable suture wing are provided for securing the catheter after initial placement.
The cross-section of the oval shaft contains two round arterial and venous lumens. The arterial lumen exit is bevelled and is perforated with two holes. The venous lumen extends beyond the arterial lumen and ends with a soft atraumatic black tip. The Niagara™ catheters are available in a straight configuration with 15cm, 20cm, and 24cm insertion lengths; as well as in a pre-curved configuration with 12.5 cm, 15 cm and 20 cm insertion lengths.
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K Number
K964881Device Name
ULTRAVERSE PTA CATHETER
Manufacturer
VAS-CATH, INC.
Date Cleared
1997-05-28
(174 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
VAS-CATH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Ultraverse™ Small Vessel Peripheral Balloon Dilatation Catheters are recommended for use in the peripheral vascular system, in the following vessels: renal, tibial, popliteal, femoral, and peroneal. This catheter is not for use in coronary arteries. The device is for single use only and must not be resterilized or reused.
Device Description
The Vas-Cath Ultraverse™ PTA Catheter is a duai lumen catheter with a balloon mounted on its distal tip. One lumen accomodates the insertion guidewire and the second provides a channel for inflation on the balloon with contrast media. The catheters were designed to be used in conjuction with a 0.016 inch diameter guidewire. There are two radiopaque marker bands placed beneath the balloon to indicate its position within the vasculature. The balloon inflates to the stated diameter and length at an 8 atmosphere operating pressure.
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K Number
K970725Device Name
OPTI-PLAST XL 5.5 F PTA CATHETER
Manufacturer
VAS-CATH, INC.
Date Cleared
1997-05-09
(70 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
VAS-CATH, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Opti-Plast® XL 5.5 F PTA Catheter is recommended for use in the Percutaneous Transluminal Angioplasty of the Iliac and Femoral vessels. This catheter is not for use in coronary arteries. The device is indicated for single use only and indicated not to be resterilized nor reused.
Device Description
The Vas-Cath Opti-Plast® XL 5.5 F PTA Catheter is a dual lumen catheter with a balloon mounted on its distal end. One lumen accomodates the insertion guidewire and the other provides a channel for inflation and deflation of the balloon with contrast media. The catheters were designed to be used in conjuction with a 0.035 inch diameter guidewire. There are two radiopaque marker bands secured on the catheter body to indicate the position of the balloon within the vasculature. The balloon inflates to the labelled diameter and length at a 5 atmosphere operating pressure.
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