Nmi 2.8 Microcatheter
FDA 510(k) K113638 · Navilyst Medical, Inc.
510(k) numberK113638
Submission
- Device name
- Nmi 2.8 Microcatheter
- Applicant
- Navilyst Medical, Inc.
Marlborough, MA, US - Received
- December 9, 2011
- Decision date
- January 5, 2012
- 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 Nmi 2.8 Microcatheter cleared by the FDA?
Nmi 2.8 Microcatheter (K113638) received a 510(k) decision of Substantially Equivalent on January 5, 2012, 27 days after the submission was received.
What is the product code of K113638?
The FDA product code is DQO – Catheter, Intravascular, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 870.1200.