RAP Femoral Venous Cannulae
FDA 510(k) clearance K250283 · decided 2025-07-10
Clearance details
- K-number
- K250283
- Device name
- RAP Femoral Venous Cannulae
- Applicant
- LivaNova USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-01-31
- Decision date
- 2025-07-10
- Days to decision
- 160 days
- Clearance type
- Special
- Product code
- DWF
- Device class
- 2
- Regulation number
- 870.4210
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Arvada, CO, 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 |
|---|---|---|
| aura6000 system (P250013/S002) | LivaNova USA, Inc. | 2026-06-18 |
| aura6000 system (P250013/S001) | LivaNova USA, Inc. | 2026-04-30 |
| aura6000 system (P250013) | LivaNova USA, Inc. | 2026-03-18 |
| VNS Therapy® System (P970003/S253) | LivaNova USA, Inc. | 2026-03-04 |
| VNS THERAPY SYSTEM (P970003/S252) | LivaNova USA, Inc. | 2025-12-17 |
| VNS Therapy Model 3100 Programmer, VNS Therapy Model 2000 Programming Wand (P970003/S251) | LivaNova USA, Inc. | 2025-11-25 |
| VNS Therapy® System (P970003/S250) | LivaNova USA, Inc. | 2025-09-12 |
| VNS Therapy System (P970003/S248) | LivaNova USA, Inc. | 2025-09-05 |