510(k) K152136
K152136 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Recovery Cone Removal System". The FDA issued a decision of Substantially Equivalent on February 18, 2016. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2016
- Date Received
- July 31, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Percutaneous Retrieval
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type