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FDA 510(k)

CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE

K-Number: K925717 · 1993-05-07

ApplicantHuntleigh Healthcare, Inc.
Decision Date1993-05-07
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE is the device name listed in this FDA 510(k) record. The listed applicant is Huntleigh Healthcare, Inc.. It received FDA 510(k) clearance on 1993-05-07 under 510(k) number K925717. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE?

CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE is a medical device that received FDA 510(k) clearance on 1993-05-07. The listed applicant is Huntleigh Healthcare, Inc.. The 510(k) number is K925717.

When did CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE receive FDA 510(k) clearance?

CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE received FDA 510(k) clearance on 1993-05-07, under 510(k) number K925717.

Who is the listed applicant for CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE?

The FDA 510(k) record lists Huntleigh Healthcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE?

The FDA product code for CALF GARMENT DVT10(S) COMPRESSIBLE LIMB SLEEVE is JOW.

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Other records listing Huntleigh Healthcare, 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.

K032315IOP8 INTRA OPERATIVE PROBEK022786DVT60K010744FLOWTRON UNIVERSAL, MODEL AC600K012008STS RANGE , MODELS STS20,STS30,STS40K002186VASCULAR ASSISTK010894BABY DOPPLEX 3002 (BD3002)

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Related Devices (Code: JOW)

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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

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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