510(k) K123445
K123445 is an FDA 510(k) premarket notification submitted by Navilyst Medical, Inc. for the device "NMI COAXIAL MICROINTRODUCER SET". The FDA issued a decision of Substantially Equivalent on April 1, 2013. The device falls under product code DRE (Dilator, Vessel, For Percutaneous Catheterization), a Class II device regulated under 21 CFR 870.1310. Navilyst Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 2013
- Date Received
- November 8, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Dilator, Vessel, For Percutaneous Catheterization
- Device Class
- Class II
- Regulation Number
- 870.1310
- Review Panel
- CV
- Submission Type