510(k) K232987
- Device
- FlowArt Valve for Vial Access
- Applicant
- Asset Medikal Tasarim Sanayi VE Ticaret A.S.
- 510(k) number
- K232987
- Product code
- LHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2024-06-26
- Date received
- 2023-09-22
- Regulation
- 880.5440
- Classification name
- Set, I.V. Fluid Transfer
- Medical specialty
- General Hospital
- Review panel
- General Hospital
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- Ebru Sirali
- Address
- Ikitelli Osb Mah., 17. Cd, No:17 Basaksehir Istanbul TR 34303 34303
FDA Registration Numbers#
- 1526863
- 2523676
- 2245590
- 1314417
- 3008824097
- 3007829657
- 3013820501
- 1833470
- 3014312726
- 3012302888
- 3016418550
- 3030201489
- 3004201393
- 8020347
- 3038356900
- 3013561817
- 1423662
- 1035907
- 9610825
- 1450662
- 9611665
- 1055927
- 3013319212
- 2032112
- 3012429465
- 9681240
- 3006610642
- 3009756327
- 3007880912
- 2244478
- 3011802635
- 3009265194
- 3001124136
- 1720929
- 3003768277
- 3015531959
- 1048735
- 3004194523
- 9615050
- 3011392709
- 3003152976
- 3016566166
- 3014342658
- 3020706315
- 3008729892
- 3030447506
- 3044026004
- 3012307300
- 2032098
- 1056553
- 3006946348
- 3013298431
- 3010659131
- 1713468
- 9681819
- 9710643
- 1047843
- 3006979803
- 3005042488
- 3013234390
- 3004548776
- 1420088
- 3018503755
- 2245304
- 3017636737
- 2650143
- 1018470
- 1724474
- 3013188547
- 3015176617
- 3045322464
- 3042177665
- 8021083
- 3023851856
- 3022555290
- 3043226252
- 2016945
- 2024024
- 9617594
- 1019003
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LHI#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252987 | ADRx™ Admixture Device | Epic Medical Pte. , Ltd. | 2026-06-12 |
| K260301 | Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2026-06-05 |
| K250345 | Medline Bag Decanter | Medline Industries, LP | 2025-10-24 |
| K251715 | FlowArt® Vial Access Device Vented | Asset Medikal | 2025-10-14 |
| K251676 | Medline Microtek C-Flo Bag Decanter, Sterile (2000S); Medline Microtek Bag Decanter II, Sterile (2002S); Medline Microtek Vial Decanter, Sterile (2006S); Medline Microtek Transfer Device, Sterile (2008S) | Microtek Medical, LLC | 2025-09-16 |
| K243404 | HyHub™ and HyHub™ Duo Vial Access Devices | Takeda Pharmaceuticals | 2025-07-18 |
| K240761 | Arisure® Closed Male Luer with Spike Adapter (YM060) | Yukon Medical, LLC | 2025-03-21 |
| K243985 | Rio™ Drug Reconstitution Transfer Device | Icu Medical, Inc. | 2025-01-22 |
| K243486 | SmartSiteTM Vented Vial Access Device | Yukon Medical, LLC | 2024-12-06 |
| K241976 | nextaro® va, 15mm, 5µm | Sfm Medical Devices GmbH | 2024-09-06 |
| K233287 | Vent Vial Adapter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-07-26 |
| K240940 | Vial2Bag Advanced® 20mm Admixture Device | West Pharmaceutical Services, Inc. | 2024-05-03 |
| K233284 | Vial Adapter with Filter | Hangzhou Qiantang Longyue Biotechnology Co., Ltd. | 2024-05-01 |
| K240748 | nextaro® v, 20/20 | Sfm Medical Devices GmbH | 2024-04-16 |
| K233021 | BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access Device | Care Fusion | 2024-03-06 |