FlowArt® A1010H-S
by Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi
FlowArt A1010H-S 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 08699443580044), 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 | Number08699443580044 | Date22 Mar 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK222889 | Date20 Jan 2023 | StatusActive |
Official records
- AccessGUDID record 08699443580044
- FDA 510(k) database K222889
Across registries
- FDA 510(k) K222889 decided 20 Jan 2023 Active
- FDA GUDID UDI-DI 08699443580044 listed 22 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K222889
- Listed FDA GUDID 08699443580044
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- Withdrawn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-S
- Primary DI / UDI-DI
- 08699443580044
- 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
Similar devices
Other devices filed under FDA product code FPA (Set, Administration, Intravascular).
- Primary & Secondary I.V. Tubing Sets by David Simmonds Co., Inc.
- Free Flow Safety Device by Migada, Ltd.
- AMSafe® 6 in. (15cm) Bifurcated Ext. Set MB4BR06 by AMSINO INTERNATIONAL, INC.
- HIgH-Flo™ Needle Set RMS62604 by REPRO MED SYSTEMS, INC.
- A6 Luer Access Device by B. Braun Medical, Inc.
- ProSeal Closed System Administration Set by Epic Medical Pte., Ltd.
- EXEL I.V. Administration Set by Exelint Intl. Co.
- Pharmacia Deltec Bag Spike Set by Pharmacia Deltec, Inc.
- AMSafe® 5 in. (13cm) MicroBore Bifurcated Ext. Set MB4BR05 by AMSINO INTERNATIONAL, INC.
- Surecan Safety Huber Needle Infusion Sets by B. Braun Medical, Inc.
Other devices from Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi
See all devices from Asset Medikal Tasarim Sanayi Ve Ticaret Anonim Sirketi →