Decision Date2016-01-13
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
IntraNovo Microcatheter is a medical device manufactured by Texasmedical Technologies, Inc.. It received FDA 510(k) clearance on 2016-01-13 under approval 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. It is manufactured by Texasmedical Technologies, Inc.. The 510(k) number is K153125.
When was IntraNovo Microcatheter approved by the FDA?
IntraNovo Microcatheter received FDA 510(k) clearance on 2016-01-13, under approval number K153125.
What company makes IntraNovo Microcatheter?
IntraNovo Microcatheter is manufactured by Texasmedical Technologies, Inc..
What is the FDA product code for IntraNovo Microcatheter?
The FDA product code for IntraNovo Microcatheter is DQO.
Other Devices by Texasmedical Technologies, Inc.
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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.