FDA 510(k)

IntraNovo Microcatheter

K-Number: K153125 · 2016-01-13

ApplicantTexasmedical Technologies, Inc.

Decision Date2016-01-13

Product CodeDQO

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

IntraNovo Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Texasmedical Technologies, Inc.. It received FDA 510(k) clearance on 2016-01-13 under 510(k) number K153125. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IntraNovo Microcatheter?

IntraNovo Microcatheter is a medical device that received FDA 510(k) clearance on 2016-01-13. The listed applicant is Texasmedical Technologies, Inc.. The 510(k) number is K153125.

When did IntraNovo Microcatheter receive FDA 510(k) clearance?

IntraNovo Microcatheter received FDA 510(k) clearance on 2016-01-13, under 510(k) number K153125.

Who is the listed applicant for IntraNovo Microcatheter?

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

What is the FDA product code for IntraNovo Microcatheter?

The FDA product code for IntraNovo Microcatheter is DQO.

Other records listing Texasmedical Technologies, 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.

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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.