510(k) K201452

Groshong NXT PICC Catheter by C.R. Bard, Inc. — Product Code LJS

K201452 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "Groshong NXT PICC Catheter". The FDA issued a decision of Substantially Equivalent on March 12, 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. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 12, 2021
Date Received
June 1, 2020
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