Identifiers
- 510(k) Number
- K182796 FDA 510(k)
- FDA Product Code
- PQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1252 FDA 510(k)
- Regulation Number
- 870.1252 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The WavelinQ 4F EndoAVF System is a percutaneous catheter designed for the creation of an arteriovenous fistula for hemodialysis access. It is a flexible 4F magnetic catheter that incorporates a radiofrequency (RF) electrode to deliver RF energy during the fistula creation procedure.
The system includes a distal yellow valve crosser, a cable and plug, and is supplied as a complete kit. It is classified as a Class II cardiovascular device and received FDA 510(k) clearance (K182796) under product code PQK.
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: WavelinQ™ EndoAVF System - BD, K182796 - WavelinQ 4F EndoAVF System - Cardiovascular, WavelinQ 4F EndoAVF System (K182796) — FDA 510(k) | Innolitics, WavelinQ™ EndoAVF System - BD, WavelinQ 4F EndoAVF System — FDA 510 (k) K182796 | MedTracker
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K182796 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K182796 24 fields · synced Sep 28, 2026