510(k) K162441
K162441 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "PowerPICC Provena Catheters with SOLO Valve Technology". The FDA issued a decision of Substantially Equivalent on Apr 24, 2017. The device falls under product code LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days), a Class II device regulated under 21 CFR 880.5970. C.R. Bard, Inc. has 645 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 24, 2017
- Date Received
- Aug 31, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Device Class
- Class II
- Regulation Number
- 880.5970
- Review Panel
- HO
- Submission Type
- 510(k)