LimFlow ARC AC-US-23
LimFlow ARC AC-US-23 is a Class II device made by Inari Medical, Inc., cleared under FDA 510(k) K251376 on 31 May 2025 (1 earlier submission) and listed in FDA GUDID since 19 Apr 2024 (UDI-DI 00850041730158), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k) 510(k) | NumberK251376 | Date31 May 2025 | StatusActive |
| United States | GUDID listing GUDID | Number00850041730158 | Date19 Apr 2024 | StatusListed |
Official records
- AccessGUDID record 00850041730158
- FDA 510(k) database K251376
- FDA 510(k) database K221541
Across registries
- FDA 510(k) K251376 decided 31 May 2025 Active
- FDA GUDID UDI-DI 00850041730158 listed 19 Apr 2024 Listed
Timeline
- Cleared FDA 510(k) K221541
- Listed FDA GUDID 00850041730158
- Cleared FDA 510(k) K251376
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- LimFlow ARC
- Generic name
- Vascular guide-catheter, single-use
- Model / Ref / Catalog
- AC-US-23
- Primary DI / UDI-DI
- 00850041730158
- FDA product code
- PDU
- GMDN term
- Vascular guide-catheter, single-use
- Device class
- Class II
- Regulation number
- 870.1250
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Vascular guide-catheter, single-use.