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FDA 510(k)

TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

K-Number: K071741 · 2007-09-24

ApplicantMigada Plant
Decision Date2007-09-24
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Migada Plant. It received FDA 510(k) clearance on 2007-09-24 under 510(k) number K071741. 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 TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM?

TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM is a medical device that received FDA 510(k) clearance on 2007-09-24. The listed applicant is Migada Plant. The 510(k) number is K071741.

When did TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM receive FDA 510(k) clearance?

TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM received FDA 510(k) clearance on 2007-09-24, under 510(k) number K071741.

Who is the listed applicant for TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM?

The FDA 510(k) record lists Migada Plant as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM?

The FDA product code for TEVADAPTOR, CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM is LHI.

Related Clinical Trials

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.

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Other records listing Migada Plant 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.

K121269TBAK051669TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM

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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