Vascular Closure System (VCS)-VASCADE 5F Vascular Closure System, VASCADE 6/7F Vascular Closure System, VASCADE MVP Veno
FDA premarket approval P120016/S038 · decided 2025-01-15
Approval details
- PMA number
- P120016
- Supplement
- S038
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Vascular Closure System (VCS)-VASCADE 5F Vascular Closure System, VASCADE 6/7F Vascular Closure System, VASCADE MVP Veno
- Generic name
- Device, hemostasis, vascular
- Applicant
- Cardiva Medical, Inc.
- Date received
- 2024-12-17
- Decision date
- 2025-01-15
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- MGB
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Santa Clara, CA
- Statement
- implementation of pre-sterilization pyrogen testing and a new pyrogen testing supplier
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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 |