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510(k) K140402

Device
MEDSOURCE IV ADMINISTRATION SET 72 MEDSOURCE IV ADMINISTRATION SET, NEEDLELESS MALE ADAPTER, MEDSOURCE IV EXTENSION SET
Applicant
MEDSOURCE INTERNATIONAL, LLC.
510(k) number
K140402
Product code
LHI  
Decision
Substantially Equivalent (SESE)
Decision date
2014-04-03
Date received
2014-02-18
Regulation
880.5440
Classification name
Set, I.v. Fluid Transfer
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Special
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
JENNIFER NESS
Address
5346 Shoreline Dr. Mound MN US 55364 55364

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LHI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2026-06-05
K250345Medline Bag DecanterMedline Industries, LP2025-10-24
K251715FlowArt® Vial Access Device VentedAsset Medikal2025-10-14
K251676Medline 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, LLC2025-09-16
K243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals2025-07-18
K240761Arisure® Closed Male Luer with Spike Adapter (YM060)Yukon Medical, LLC2025-03-21
K243985Rio™ Drug Reconstitution Transfer DeviceIcu Medical, Inc.2025-01-22
K243486SmartSiteTM Vented Vial Access DeviceYukon Medical, LLC2024-12-06
K241976nextaro® va, 15mm, 5µmSfm Medical Devices GmbH2024-09-06
K233287Vent Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-07-26
K232987FlowArt Valve for Vial AccessAsset Medikal Tasarim Sanayi VE Ticaret A.S.2024-06-26
K240940Vial2Bag Advanced® 20mm Admixture DeviceWest Pharmaceutical Services, Inc.2024-05-03
K233284Vial Adapter with FilterHangzhou Qiantang Longyue Biotechnology Co., Ltd.2024-05-01
K240748nextaro® v, 20/20Sfm Medical Devices GmbH2024-04-16
K233021BD SmartSite™ 13mm Vial Access Device; BD SmartSite™ 20mm Vial Access DeviceCare Fusion2024-03-06

Legacy Summary#

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FDA Review#

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