LimFlow System
FDA premarket approval P220025/S006 · decided 2025-07-09
Approval details
- PMA number
- P220025
- Supplement
- S006
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- LimFlow System
- Generic name
- Stent graft, infrapopliteal, venous arterialization
- Applicant
- LimFlow, Inc.
- Date received
- 2025-06-09
- Decision date
- 2025-07-09
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- QWN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- to allow limited rework of the device implant component
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| LimFlow Vector (K260188) | LimFlow, Inc. | 2026-03-18 |
| LimFlow ARC (K251376) | LimFlow, Inc. | 2025-05-31 |
| LimFlow V-Ceiver (K242776) | LimFlow, Inc. | 2025-02-14 |
| LimFlow Vector (K221902) | LimFlow, Inc. | 2022-12-21 |
| LimFlow ARC (K221541) | LimFlow, Inc. | 2022-08-31 |
| LimFlow V-Ceiver (K222083) | LimFlow, Inc. | 2022-08-09 |