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FDA 510(k)

VORTRAN Cuff Inflator (VCI)

K-Number: K173914 · 2018-05-25

ApplicantVortran Medical Technology 1, Inc.
Decision Date2018-05-25
Product CodeBSK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

VORTRAN Cuff Inflator (VCI) is the device name listed in this FDA 510(k) record. The listed applicant is Vortran Medical Technology 1, Inc.. It received FDA 510(k) clearance on 2018-05-25 under 510(k) number K173914. The device is classified under product code BSK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VORTRAN Cuff Inflator (VCI)?

VORTRAN Cuff Inflator (VCI) is a medical device that received FDA 510(k) clearance on 2018-05-25. The listed applicant is Vortran Medical Technology 1, Inc.. The 510(k) number is K173914.

When did VORTRAN Cuff Inflator (VCI) receive FDA 510(k) clearance?

VORTRAN Cuff Inflator (VCI) received FDA 510(k) clearance on 2018-05-25, under 510(k) number K173914.

Who is the listed applicant for VORTRAN Cuff Inflator (VCI)?

The FDA 510(k) record lists Vortran Medical Technology 1, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VORTRAN Cuff Inflator (VCI)?

The FDA product code for VORTRAN Cuff Inflator (VCI) is BSK.

Other records listing Vortran Medical Technology 1, Inc. 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.

K202219VORTRAN GO2VENT with PEEP ValveK182292VORTRAN APM-PlusK162968VORTRAN GO2VENTK153733VORTRAN Manometer

Related Devices (Code: BSK)

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.

K261499TrachFlushAw Technologies ApsK243562CuffGuardIdmedK242642CuffTrekShanghai Longmann Tech Co., Ltd.K220854TrachCuff Cuff ControllerAw Technologies ApsK221477AG100sHospitech Respiration , Ltd.K202874Puritan Bennett Cuff Pressure ManagerCovidien, LLC

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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