The following data is part of a premarket notification filed by Cardiva Medical, Inc. with the FDA for Catalyst Ii And Iii.
| Device ID | K130124 |
| 510k Number | K130124 |
| Device Name: | CATALYST II AND III |
| Classification | Clamp, Vascular |
| Applicant | CARDIVA MEDICAL, INC. 8 SNOWBERRY CT. Orinda, CA 94563 |
| Contact | Michael A Daniel |
| Correspondent | Michael A Daniel CARDIVA MEDICAL, INC. 8 SNOWBERRY CT. Orinda, CA 94563 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-01-17 |
| Decision Date | 2013-03-14 |
| Summary: | summary |