510(k) K152387
K152387 is an FDA 510(k) premarket notification submitted by Vascular Solutions, Inc. for the device "Fluent Inflation Device". The FDA issued a decision of Substantially Equivalent (kit) on December 18, 2015. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Vascular Solutions, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- December 18, 2015
- Date Received
- August 24, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Syringe, Balloon Inflation
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- CV
- Submission Type