BOOMERANG WIRE
FDA 510(k) clearance K061075 · decided 2006-09-01
Clearance details
- K-number
- K061075
- Device name
- BOOMERANG WIRE
- Applicant
- Cardiva Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2006-04-17
- Decision date
- 2006-09-01
- Days to decision
- 137 days
- Clearance type
- Special
- Product code
- DXC
- Device class
- 2
- Regulation number
- 870.4450
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Moutian View, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Vascular Closure System (VCS)-VASCADE 5F Vascular Closure System, VASCADE 6/7F Vascular Closure System, VASCADE MVP Veno (P120016/S038) | Cardiva Medical, Inc. | 2025-01-15 |
| Cardiva VASCADE MVP XL Venous Vascular Closure System (VVCS) (P120016/S037) | Cardiva Medical, Inc. | 2024-11-19 |
| Vascular Closure System (VCS) (P120016/S036) | Cardiva Medical, Inc. | 2024-04-26 |
| Cardiva VASCADE Family (P120016/S035) | Cardiva Medical, Inc. | 2024-01-08 |
| Cardiva VASCADE Family (P120016/S034) | Cardiva Medical, Inc. | 2024-01-03 |
| Cardiva VASCADE Family (P120016/S031) | Cardiva Medical, Inc. | 2023-12-29 |
| Cardiva VASCADE Family (P120016/S033) | Cardiva Medical, Inc. | 2023-12-28 |
| Vascade Vascular Closure System (VCS) (P120016/S029) | Cardiva Medical, Inc. | 2023-03-01 |