510(k) K210264

BD PowerPiCC Catheter by Bard Access Systems, Inc. — Product Code LJS

K210264 is an FDA 510(k) premarket notification submitted by Bard Access Systems, Inc. for the device "BD PowerPiCC Catheter". The FDA issued a decision of Substantially Equivalent on July 30, 2021. 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. Bard Access Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 2021
Date Received
February 1, 2021
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