510(k) K122321
K122321 is an FDA 510(k) premarket notification submitted by Merit Medical Ireland, Ltd. for the device "BASIXCONPAK ANALOG INFLATION SYRINGE". The FDA issued a decision of Substantially Equivalent on December 19, 2012. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Merit Medical Ireland, Ltd. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 19, 2012
- Date Received
- August 1, 2012
- 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