FDA 510(k)

KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN

K-Number: K012614 · 2002-05-01

ApplicantMedical Instruments Technology, Inc.

Decision Date2002-05-01

Product CodeJOW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN is the device name listed in this FDA 510(k) record. The listed applicant is Medical Instruments Technology, Inc.. It received FDA 510(k) clearance on 2002-05-01 under 510(k) number K012614. 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 KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN?

KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN is a medical device that received FDA 510(k) clearance on 2002-05-01. The listed applicant is Medical Instruments Technology, Inc.. The 510(k) number is K012614.

When did KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN receive FDA 510(k) clearance?

KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN received FDA 510(k) clearance on 2002-05-01, under 510(k) number K012614.

Who is the listed applicant for KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN?

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

What is the FDA product code for KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN?

The FDA product code for KENDALL, SEQUENTIAL COMPRESSION DEVICE; HUNTLEIGH, FLOWTRON; VENAFLOW; ACUFEX; ALPS; SHEEPSKIN is JOW.

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Other records listing Medical Instruments Technology, Inc. as applicant

K012640ELECTROSURGICAL CUTTING AND COAGULATION ACCESSORIES, ELECTROSURGICAL WANDS K012624REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS K012632TOURNIQUET CUFF; PNEUMATIC TOURNIQUET K884611THE ORTHORANGER II ELECTRONIC GONIOMETER

Related Devices (Code: JOW)

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLC K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile Medical K253386DVT 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

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