510(k) K130566
K130566 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "BASIXTOUCH". The FDA issued a decision of Substantially Equivalent on June 19, 2013. 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
- SESE (Substantially Equivalent)
- Decision Date
- June 19, 2013
- Date Received
- March 4, 2013
- 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