Venous Return Cannulae
FDA 510(k) clearance K250937 · decided 2026-03-11
Clearance details
- K-number
- K250937
- Device name
- Venous Return Cannulae
- Applicant
- LivaNova USA, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-03-28
- Decision date
- 2026-03-11
- Days to decision
- 348 days
- Clearance type
- Traditional
- 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 |
|---|---|---|
| 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 |
| VNS THERAPY SYSTEM (P970003/S247) | LivaNova USA, Inc. | 2025-05-02 |
| VNS Therapy® SenTiva® Model 1000 Generator, VNS Therapy® AspireSR Model 106 Generator, VNS Therapy® Demipulse Model 103 (P970003/S246) | LivaNova USA, Inc. | 2025-03-27 |
| VNS Therapy System (P970003/S245) | LivaNova USA, Inc. | 2024-11-14 |
| SenTiva Model 1000 and SenTiva Duo Model 1000-D 2024 Generator Firmware Maintenance (P970003/S244) | LivaNova USA, Inc. | 2024-07-18 |