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510(k) K083851

Device
INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022
Applicant
INVIRO MEDICAL DEVICES, INC.
510(k) number
K083851
Product code
LHI  
Decision
Substantially Equivalent (SESE)
Decision date
2009-05-15
Date received
2008-12-24
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
Summary
Third party reviewed
No

Applicant Contact#

Contact
JIM BARLEY
Address
1755 N. Brown Rd. Suite 150 Lawrenceville GA US 30043 30043

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LHI  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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
K231071Mix2Vial® Transfer DeviceWest Pharma. Services IL, Ltd.2024-01-19

Legacy Summary#

summary

FDA Review#

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