LimFlow System
FDA premarket approval P220025/S004 · decided 2024-12-20
Approval details
- PMA number
- P220025
- Supplement
- S004
- Supplement type
- 135 Review Track For 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
- 2024-07-23
- Decision date
- 2024-12-20
- Days to decision
- 150 days
- Decision code
- APPR
- Product code
- QWN
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- San Jose, CA
- Statement
- the use of an additional sterilization chamber for ethylene oxide sterilization at the current contract sterilization facility.
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
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 |