510(k) K080976
- Device
- NEXUS I.V. FLUID TRANSFER DEVICE
- Applicant
- NEXUS MEDICAL, LLC
- 510(k) number
- K080976
- Product code
- LHI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2008-11-10
- Date received
- 2008-04-07
- 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
- LARRY SMITH
- Address
- 11315 Strang Line Rd. Lenexa KS US 66215 66215
FDA Registration Numbers#
- 3010329663
- 3000223297
- 3006946348
- 1833470
- 3003974574
- 1061927
- 9613744
- 8021083
- 1018470
- 3003152976
- 3008729892
- 3017636737
- 3010432890
- 1019003
- 2245304
- 3015085713
- 2011171
- 1000632857
- 8031007
- 9612052
- 9611157
- 3013561817
- 2520313
- 3008717264
- 9610825
- 3006571738
- 2650143
- 3013557562
- 3013481097
- 3015972753
- 8020347
- 1035907
- 3012798826
- 2024024
- 3030446844
- 3010659131
- 3007880912
- 2523676
- 3014936217
- 9614854
- 3015276780
- 3003768277
- 3009631669
- 3009340644
- 9681819
- 1928237
- 3003704957
- 3001124136
- 1417592
- 2245270
- 3013319212
- 9710018
- 1416980
- 2521402
- 1720734
- 3006979803
- 3018503755
- 3013234390
- 3030447506
- 2953359
- 3016418550
- 3016938816
- 1217831
- 2030598
- 9616066
- 1530671
- 1410248
- 3008810357
- 2029275
- 2649614
- 3012494290
- 1223004
- 9615908
- 3013188547
- 3005245797
- 3013820501
- 3002807257
- 1526534
- 3010160527
- 1424263
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 |
| K232987 | FlowArt Valve for Vial Access | Asset Medikal Tasarim Sanayi VE Ticaret A.S. | 2024-06-26 |
| 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 |
Legacy Summary#
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FDA Review#
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