The following data is part of a premarket notification filed by Cardiva Medical, Inc. with the FDA for Boomerang Wire /boomerang Plus Wire System, Model# B Plus Wire 58l.
| Device ID | K070485 |
| 510k Number | K070485 |
| Device Name: | BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L |
| Classification | Clamp, Vascular |
| Applicant | CARDIVA MEDICAL, INC. 155 MOFFETT PARK DR., SUITE A-101 Sunnyvale, CA 94089 |
| Contact | Michael J Billig |
| Correspondent | Michael J Billig CARDIVA MEDICAL, INC. 155 MOFFETT PARK DR., SUITE A-101 Sunnyvale, CA 94089 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-20 |
| Decision Date | 2007-03-22 |
| Summary: | summary |