The following data is part of a premarket notification filed by Cardiva Medical, Inc. with the FDA for Boomerang Closurewire Vascular Closure System.
| Device ID | K051817 |
| 510k Number | K051817 |
| Device Name: | BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM |
| Classification | Clamp, Vascular |
| Applicant | CARDIVA MEDICAL, INC. P.O. BOX 10925 Pleasanton, CA 94588 |
| Contact | Karin Gastineau |
| Correspondent | Karin Gastineau CARDIVA MEDICAL, INC. P.O. BOX 10925 Pleasanton, CA 94588 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-07-05 |
| Decision Date | 2006-12-06 |
| Summary: | summary |