The following data is part of a premarket notification filed by Cardiva Medical, Inc. with the FDA for Cardiva Catalyst Iii System With Protamine Sulfate.
| Device ID | K082930 |
| 510k Number | K082930 |
| Device Name: | CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE |
| 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 | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2008-10-01 |
| Decision Date | 2009-02-13 |
| Summary: | summary |