LimFlow ARC
FDA 510(k) clearance K221541 · decided 2022-08-31
Clearance details
- K-number
- K221541
- Device name
- LimFlow ARC
- Applicant
- LimFlow, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-05-27
- Decision date
- 2022-08-31
- Days to decision
- 96 days
- Clearance type
- Traditional
- Product code
- PDU
- Device class
- 2
- Regulation number
- 870.1250
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- San Jose, 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 |
|---|---|---|
| LimFlow System (P220025/S007) | LimFlow, Inc. | 2025-10-22 |
| LimFlow System (P220025/S006) | LimFlow, Inc. | 2025-07-09 |
| LimFlow System, LimFlow Crossing Stent Graft and LimFLow Extension Stent Graft (P220025/S005) | LimFlow, Inc. | 2025-02-12 |
| LimFlow System (P220025/S004) | LimFlow, Inc. | 2024-12-20 |
| LimFlow System, LimFlow Crossing Stent Graft, LimFlow Extension Stent Graft (P220025/S002) | LimFlow, Inc. | 2024-07-11 |
| LimFlow System (P220025/S003) | LimFlow, Inc. | 2024-04-19 |
| LimFlow System (P220025/S001) | LimFlow, Inc. | 2023-10-12 |
| LimFlow System (P220025) | LimFlow, Inc. | 2023-09-11 |