Viatrac 14 Plus Peripheral Dilatation Catheter
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K221057 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 Viatrac 14 Plus Peripheral Dilatation Catheter is a catheter, angioplasty, peripheral, transluminal device designed for vascular interventions. It is a flexible distal catheter with a hydrophobic coating and a rapid exchange system, intended for dilatation of stenoses in peripheral arteries.
This device is supplied for one-time use only and must not be resterilized or reused. It is indicated for use in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, as well as for the treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. The device is not intended for use in coronary arteries.
Frequently asked questions
What is the Viatrac 14 Plus Peripheral Dilatation Catheter used for?
The Viatrac 14 Plus Peripheral Dilatation Catheter is designed for vascular interventions, specifically for dilatation of stenoses in peripheral arteries including iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, as well as for treating obstructive lesions in native or synthetic arteriovenous dialysis fistulae.
Is the Viatrac 14 Plus Peripheral Dilatation Catheter reusable?
No, the Viatrac 14 Plus Peripheral Dilatation Catheter is supplied for one-time use only and must not be resterilized or reused. This is important for patient safety and device performance.
What are the key features of the Viatrac 14 Plus Peripheral Dilatation Catheter?
The Viatrac 14 Plus Peripheral Dilatation Catheter is a flexible distal catheter with a hydrophobic coating and a rapid exchange system. These features enhance its maneuverability and performance during peripheral vascular interventions.
In which arteries can the Viatrac 14 Plus Peripheral Dilatation Catheter be used?
The device is indicated for use in the iliac, femoral, ilio-femoral, popliteal, infra popliteal, and renal arteries, as well as for the treatment of obstructive lesions in native or synthetic arteriovenous dialysis fistulae. It is not intended for use in coronary 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: Viatrac 14 Plus Peripheral Dilatation Catheter | Abbott, Ordering Information for Viatrac 14 Plus Catheters | Abbott, Rx Viatrac 14 Plus Peripheral Dilatation Catheters
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221057 | Class II | Active |
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Manufacturer
- Manufacturer
- Abbott Vascular
Sources (1)
- FDA 510(k) K221057 24 fields · synced Sep 22, 2026