510(k) K153672
K153672 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "basixTOUCH40 Inflation Syringe". The FDA issued a decision of Substantially Equivalent (kit) on January 20, 2016. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- January 20, 2016
- Date Received
- December 21, 2015
- Clearance Type
- Special
- 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