The following data is part of a De Novo classification by Avenu Medical, Inc with the FDA for Ellipsys Vascular Access System.
| DeNovo ID | DEN170004 |
| Device Name: | Ellipsys Vascular Access System |
| Classification | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
| Applicant | Avenu Medical, Inc 27123 Calle Arroyo, Suite 2101 San Juan Capistrano, CA 92675 |
| Contact | Rebecca K. Pine |
| 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 | 2017-01-10 |
| Decision Date | 2018-06-22 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B357AMI6050 | DEN170004 | 000 |
| B357AMI1000 | DEN170004 | 000 |