510(k) K143522
K143522 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Presto Inflation Device". The FDA issued a decision of Substantially Equivalent on January 12, 2015. The device falls under product code MAV (Syringe, Balloon Inflation), a Class II device regulated under 21 CFR 870.1650. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 12, 2015
- Date Received
- December 12, 2014
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Syringe, Balloon Inflation
- Device Class
- Class II
- Regulation Number
- 870.1650
- Review Panel
- CV
- Submission Type