Headway Duo Microcatheter
FDA 510(k) K120917 · MicroVention, Inc.
510(k) numberK120917
Submission
- Device name
- Headway Duo Microcatheter
- Applicant
- MicroVention, Inc.
Tistin, CA, US - Received
- March 27, 2012
- Decision date
- August 2, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Headway Duo Microcatheter cleared by the FDA?
Headway Duo Microcatheter (K120917) received a 510(k) decision of Substantially Equivalent on August 2, 2012, 128 days after the submission was received.
What is the product code of K120917?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.