| DeNovo ID | DEN190038 |
| Device Name: | Surfacer Inside-Out Access Catheter System |
| Classification | Reverse Central Venous Recanalization System |
| Applicant | Bluegrass Vascular Technologies, Inc. 12500 Network Boulevard, Suite 308 San Antonio, TX 78249 |
| Contact | Gabriele G. Niederauer |
| Product Code | QJH |
| CFR Regulation Number | 870.1342 [🔎] |
| 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 | 2019-08-15 |
| Decision Date | 2020-02-10 |
| Reclassification Order: | Reclassification Order |