Fortrex 0.035 OTW PTA Balloon Catheter
FDA 510(k)Class II (US FDA 510(k))
by Covidien llc
Identifiers
- 510(k) Number
- K142654 FDA 510(k)
- FDA Product Code
- LIT FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Fortrex 0.035 OTW PTA Balloon Catheter is an over-the-wire dual lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. It is designed for percutaneous transluminal angioplasty (PTA) to dilate stenotic peripheral arteries by controlled inflation of a distensible balloon at its distal tip. The catheter includes a manifold with a lumen marked 'THRU', which is the central lumen terminating at the distal tip.
This sterile, non-drug-eluting catheter is supplied for single use and is intended for peripheral (non-cerebral, non-coronary) artery procedures. It is available in various sizes as specified by the model numbers. The device has received FDA 510(k) clearance with the product code LIT and is classified as Class II, regulation number 870.1250.
Frequently asked questions
What is the Fortrex 0.035 OTW PTA Balloon Catheter used for?
The Fortrex 0.035 OTW PTA Balloon Catheter is designed for percutaneous transluminal angioplasty (PTA) to dilate stenotic peripheral arteries by controlled inflation of a distensible balloon at its distal tip. It is intended for peripheral (non-cerebral, non-coronary) artery procedures.
How is the Fortrex 0.035 OTW PTA Balloon Catheter supplied?
The Fortrex 0.035 OTW PTA Balloon Catheter is supplied as a sterile, non-drug-eluting catheter for single use. It is available in various sizes as specified by the model numbers, and includes a manifold with a lumen marked 'THRU' which is the central lumen terminating at the distal tip.
What is the regulatory status of the Fortrex 0.035 OTW PTA Balloon Catheter?
The device has received FDA 510(k) clearance with the product code LIT and is classified as Class II, regulation number 870.1250. It was determined to be substantially equivalent through the traditional clearance process.
What are the key features of the Fortrex 0.035 OTW PTA Balloon Catheter?
The Fortrex 0.035 OTW PTA Balloon Catheter is an over-the-wire dual lumen catheter with a distally mounted semi-compliant inflatable balloon and an atraumatic tapered tip. It is designed for controlled inflation to dilate stenotic peripheral arteries.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Fortrex™ HP PTA balloon catheter - Medtronic, PDF Fortrex - Food and Drug Administration, 0.035 IN OTW PTA Balloon Catheter - porlive.azurewebsites.net
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142654 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Covidien llc
- FDA Applicant
- Covidien, LLC
Sources (1)
- FDA 510(k) K142654 24 fields · synced Sep 25, 2026