IntraNovo Microcatheter
FDA 510(k) K153125 · Texasmedical Technologies, Inc.
510(k) numberK153125
Submission
- Device name
- IntraNovo Microcatheter
- Applicant
- Texasmedical Technologies, Inc.
El Paso, TX, US - Received
- October 29, 2015
- Decision date
- January 13, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQO – Catheter, Intravascular, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
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Questions and answers
When was IntraNovo Microcatheter cleared by the FDA?
IntraNovo Microcatheter (K153125) received a 510(k) decision of Substantially Equivalent on January 13, 2016, 76 days after the submission was received.
What is the product code of K153125?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.