Nmi Coaxial Microintroducer Set
FDA 510(k) K132713 · Navilyst Medical, Inc.
510(k) numberK132713
Submission
- Device name
- Nmi Coaxial Microintroducer Set
- Applicant
- Navilyst Medical, Inc.
Marlborough, MA, US - Received
- August 30, 2013
- Decision date
- September 27, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
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Questions and answers
When was Nmi Coaxial Microintroducer Set cleared by the FDA?
Nmi Coaxial Microintroducer Set (K132713) received a 510(k) decision of Substantially Equivalent on September 27, 2013, 28 days after the submission was received.
What is the product code of K132713?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.