The following data is part of a premarket notification filed by Cardiva Medical, Inc. with the FDA for Boomerang Wire.
| Device ID | K061075 |
| 510k Number | K061075 |
| Device Name: | BOOMERANG WIRE |
| Classification | Clamp, Vascular |
| Applicant | CARDIVA MEDICAL, INC. 2585 LEGHORN ST. Mountain View, CA 94043 |
| Contact | Glenn Foy |
| Correspondent | Glenn Foy CARDIVA MEDICAL, INC. 2585 LEGHORN ST. Mountain View, CA 94043 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-17 |
| Decision Date | 2006-09-01 |
| Summary: | summary |