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 a medical device manufactured by Vortran Medical Technology 1, Inc.. It received FDA 510(k) clearance on 2018-05-25 under approval 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. It is manufactured by Vortran Medical Technology 1, Inc.. The 510(k) number is K173914.

When was VORTRAN Cuff Inflator (VCI) approved by the FDA?

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

What company makes VORTRAN Cuff Inflator (VCI)?

VORTRAN Cuff Inflator (VCI) is manufactured by Vortran Medical Technology 1, Inc..

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

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

Other Devices by Vortran Medical Technology 1, Inc.

K153733VORTRAN Manometer K162968VORTRAN GO2VENT K182292VORTRAN APM-Plus K202219VORTRAN GO2VENT with PEEP Valve

Related Devices (Code: BSK)

K152778TRACOE Cuff Pressure MonitorTracoe Medical GmbH K152865TRACOE smart Cuff ManagerTracoe Medical GmbH K150157AnapnoGuard 100 Respiratory Guard SystemHospitech Respiration , Ltd. K150893IntelliCuffHamilton Medical AG K180991AG 100sHospitech Respiration , Ltd. K182548Accucuff Cuff Pressure IndicatorTianjin Medis Medical Device Co., Ltd.

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.