Cardiva VASCADE Family
FDA premarket approval P120016/S034 · decided 2024-01-03
Approval details
- PMA number
- P120016
- Supplement
- S034
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Cardiva VASCADE Family
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cardiva Medical, Inc.
- Date received
- 2023-12-05
- Decision date
- 2024-01-03
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- an additional controlled environment room at the approved Guaymas facility (Sonora, Mexico) for the Cardiva Vascade Family
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| CATALYST II AND III (K130124) | Cardiva Medical, Inc. | 2013-03-14 |
| CARDIVA CATALYST III SYSTEM WITH PROTAMINE SULFATE (K082930) | Cardiva Medical, Inc. | 2009-02-13 |
| BOOMERANG CATALYST/BOOMERANG CATALYST II SYSTEM (K072297) | Cardiva Medical, Inc. | 2007-09-12 |
| BOOMERANG WIRE /BOOMERANG PLUS WIRE SYSTEM, MODEL# B PLUS WIRE 58L (K070485) | Cardiva Medical, Inc. | 2007-03-22 |
| BOOMERANG CLOSUREWIRE VASCULAR CLOSURE SYSTEM (K051817) | Cardiva Medical, Inc. | 2006-12-06 |
| BOOMERANG WIRE (K061075) | Cardiva Medical, Inc. | 2006-09-01 |
| VASOSTASIS VASCULAR CLOSURE SYSTEM (K041486) | Cardiva Medical, Inc. | 2004-10-22 |