The following data is part of a De Novo classification by Tva Medical, Inc. with the FDA for Everlinq Endoavf System.
| DeNovo ID | DEN160006 |
| Device Name: | EverlinQ EndoAVF System |
| Classification | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
| Applicant | TVA Medical, Inc. 7000 Bee Cave Rd Austin, TX 78746 |
| Contact | Noah Bartsch |
| Product Code | PQK |
| CFR Regulation Number | 870.1252 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Cardiovascular |
| Classification Advisory | Cardiovascular |
| Type | Direct |
| Date Received | 2016-02-03 |
| Decision Date | 2018-06-22 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868260000211 | DEN160006 | 000 |