FDA 510(k)

VENODYNE DVT ADVANTAGE MODEL 610

K-Number: K001802 · 2001-01-09

Decision Date2001-01-09

Product CodeJOW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

VENODYNE DVT ADVANTAGE MODEL 610 is the device name listed in this FDA 510(k) record. The listed applicant is Microtek Medical, Inc.. It received FDA 510(k) clearance on 2001-01-09 under 510(k) number K001802. 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 VENODYNE DVT ADVANTAGE MODEL 610?

VENODYNE DVT ADVANTAGE MODEL 610 is a medical device that received FDA 510(k) clearance on 2001-01-09. The listed applicant is Microtek Medical, Inc.. The 510(k) number is K001802.

When did VENODYNE DVT ADVANTAGE MODEL 610 receive FDA 510(k) clearance?

VENODYNE DVT ADVANTAGE MODEL 610 received FDA 510(k) clearance on 2001-01-09, under 510(k) number K001802.

Who is the listed applicant for VENODYNE DVT ADVANTAGE MODEL 610?

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

What is the FDA product code for VENODYNE DVT ADVANTAGE MODEL 610?

The FDA product code for VENODYNE DVT ADVANTAGE MODEL 610 is JOW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITING NCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITING NCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDED NCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Microtek Medical, Inc. as applicant

K110358VENODYNE V810 K102971FREEDOMAIRE III SURGICAL HELMET SYSTEM MODEL 10322STK K062899MICROTEK MEDICAL SURGICAL GOWN/TOGA K060200MICROTEK MEDICAL WARMING DRAPE K050322MICROTEK EQUIPMENT DRAPES K022903CHILLBUSTER

View all 24 devices →

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

View on FDA Database →

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