510(k) K140745
K140745 is an FDA 510(k) premarket notification submitted by Boston Scientific Corp for the device "ENCORE 26 ADVANTAGE KIT". The FDA issued a decision of Substantially Equivalent (kit) on April 17, 2014. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. Boston Scientific Corp has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- April 17, 2014
- Date Received
- March 25, 2014
- 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