510(k) K180548

3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology by C.R. Bard, Inc (Bard Has Joined Bd) — Product Code LJS

K180548 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc (Bard Has Joined Bd) for the device "3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology". The FDA issued a decision of Substantially Equivalent on Apr 26, 2018. 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.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Apr 26, 2018
Date Received
Mar 1, 2018
Clearance Type
Special
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)