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FDA 510(k)

VENODYNE V810

K-Number: K110358 · 2011-05-05

ApplicantMicrotek Medical, Inc.
Decision Date2011-05-05
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

VENODYNE V810 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 2011-05-05 under 510(k) number K110358. 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 V810?

VENODYNE V810 is a medical device that received FDA 510(k) clearance on 2011-05-05. The listed applicant is Microtek Medical, Inc.. The 510(k) number is K110358.

When did VENODYNE V810 receive FDA 510(k) clearance?

VENODYNE V810 received FDA 510(k) clearance on 2011-05-05, under 510(k) number K110358.

Who is the listed applicant for VENODYNE V810?

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 V810?

The FDA product code for VENODYNE V810 is JOW.

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Other records listing Microtek Medical, Inc. as applicant

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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.

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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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