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FDA 510(k)

MEDSOURCE IV ADMINSTRATION SET

K-Number: K120424 · 2012-07-11

ApplicantMedsource International, LLC
Decision Date2012-07-11
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MEDSOURCE IV ADMINSTRATION SET is the device name listed in this FDA 510(k) record. The listed applicant is Medsource International, LLC. It received FDA 510(k) clearance on 2012-07-11 under 510(k) number K120424. The device is classified under product code LHI. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDSOURCE IV ADMINSTRATION SET?

MEDSOURCE IV ADMINSTRATION SET is a medical device that received FDA 510(k) clearance on 2012-07-11. The listed applicant is Medsource International, LLC. The 510(k) number is K120424.

When did MEDSOURCE IV ADMINSTRATION SET receive FDA 510(k) clearance?

MEDSOURCE IV ADMINSTRATION SET received FDA 510(k) clearance on 2012-07-11, under 510(k) number K120424.

Who is the listed applicant for MEDSOURCE IV ADMINSTRATION SET?

The FDA 510(k) record lists Medsource International, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MEDSOURCE IV ADMINSTRATION SET?

The FDA product code for MEDSOURCE IV ADMINSTRATION SET is LHI.

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Other records listing Medsource International, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K223788The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety CatheterK161779MedSource TrueSafe Safety IV Catheter, MedSource TrueSafe Comfort Safety IV CatheterK080339MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF)K081516MEDSOURCE CPR MASK WITH & WITHOUT OXYGEN PORT

Related Devices (Code: LHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K252987ADRx™ Admixture DeviceEpic Medical Pte. , Ltd.K260301Vial AdapterHangzhou Qiantang Longyue Biotechnology Co., Ltd.K250345Medline Bag DecanterMedline Industries, LPK251715FlowArt® Vial Access Device VentedAsset MedikalK251676Medline 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, LLCK243404HyHub™ and HyHub™ Duo Vial Access DevicesTakeda Pharmaceuticals

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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