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FDA 510(k)

VENODYNE DVT ADVANTAGE PLUS

K-Number: K011318 · 2001-10-25

Decision Date2001-10-25
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENODYNE DVT ADVANTAGE PLUS 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 2001-10-25 under 510(k) number K011318. 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 PLUS?

VENODYNE DVT ADVANTAGE PLUS is a medical device that received FDA 510(k) clearance on 2001-10-25. The listed applicant is Microtek Medical, Inc.. The 510(k) number is K011318.

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

VENODYNE DVT ADVANTAGE PLUS received FDA 510(k) clearance on 2001-10-25, under 510(k) number K011318.

Who is the listed applicant for VENODYNE DVT ADVANTAGE PLUS?

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 PLUS?

The FDA product code for VENODYNE DVT ADVANTAGE PLUS 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.

Other records listing Microtek Medical, 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.

View all 24 devices →

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.

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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