The following data is part of a premarket notification filed by Cardiva Medical, Inc. with the FDA for Boomerang Catalyst/boomerang Catalyst Ii System.
| Device ID | K072297 |
| 510k Number | K072297 |
| Device Name: | BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM |
| Classification | Clamp, Vascular |
| Applicant | CARDIVA MEDICAL, INC. 155 MOFFETT PARK DR., SUITE A-210 Sunnyvale, CA 94089 |
| Contact | Kit Cariquitan |
| Correspondent | Kit Cariquitan CARDIVA MEDICAL, INC. 155 MOFFETT PARK DR., SUITE A-210 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 | 2007-08-17 |
| Decision Date | 2007-09-12 |
| Summary: | summary |