510(k) K180913
K180913 is an FDA 510(k) premarket notification submitted by Vascular Solutions, Inc. for the device "VSI Micro-Introducer Kit". The FDA issued a decision of Substantially Equivalent on May 9, 2018. The device falls under product code DYB (Introducer, Catheter), a Class II device regulated under 21 CFR 870.1340. Vascular Solutions, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 9, 2018
- Date Received
- April 9, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Introducer, Catheter
- Device Class
- Class II
- Regulation Number
- 870.1340
- Review Panel
- CV
- Submission Type