FlowArt® A1010H-D
by Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi
FlowArt A1010H-D is a medical device (FDA Class II; FDA product code FPA, Set, Administration, Intravascular) made by Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi, cleared under FDA 510(k) K222889 on 20 Jan 2023 and listed in FDA GUDID since 22 Mar 2023 (UDI-DI 08699443580051), 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 | GUDID listing | Number08699443580051 | Date22 Mar 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222889 | Date20 Jan 2023 | StatusActive |
Official records
- AccessGUDID record 08699443580051
- FDA 510(k) database K222889
Across registries
- FDA 510(k) K222889 decided 20 Jan 2023 Active
- FDA GUDID UDI-DI 08699443580051 listed 22 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K222889
- Listed FDA GUDID 08699443580051
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- FlowArt®
- Generic name
- Negative-pressure intravenous line needleless valve-connector
- Model / reference
- A1010H-D
- Primary DI / UDI-DI
- 08699443580051
- 510(k) Number
- FDA product code
- FPA
- GMDN term
- Negative-pressure intravenous line needleless valve-connector
- Device class
- Class II
- Regulation number
- 880.5440
- GUDID distribution status
- In Commercial Distribution
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