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FDA 510(k)

EQUASHIELD SYSTEM PROTECTIVE PLUS

K-Number: K101940 · 2010-11-19

ApplicantEquashield Medical , Ltd.
Decision Date2010-11-19
Product CodeLHI
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EQUASHIELD SYSTEM PROTECTIVE PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Equashield Medical , Ltd.. It received FDA 510(k) clearance on 2010-11-19 under 510(k) number K101940. 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 EQUASHIELD SYSTEM PROTECTIVE PLUS?

EQUASHIELD SYSTEM PROTECTIVE PLUS is a medical device that received FDA 510(k) clearance on 2010-11-19. The listed applicant is Equashield Medical , Ltd.. The 510(k) number is K101940.

When did EQUASHIELD SYSTEM PROTECTIVE PLUS receive FDA 510(k) clearance?

EQUASHIELD SYSTEM PROTECTIVE PLUS received FDA 510(k) clearance on 2010-11-19, under 510(k) number K101940.

Who is the listed applicant for EQUASHIELD SYSTEM PROTECTIVE PLUS?

The FDA 510(k) record lists Equashield Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EQUASHIELD SYSTEM PROTECTIVE PLUS?

The FDA product code for EQUASHIELD SYSTEM PROTECTIVE PLUS is LHI.

Related Clinical Trials

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Other records listing Equashield Medical , Ltd. 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.

K221513Equashield Closed System Transfer DeviceK170706Equashield Closed System drug Transfer Device (CSTD)

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

View on FDA Database →

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

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