Cleared Traditional

Groshong NXT PICC Catheter

K201452 · C.R. Bard, Inc. · General Hospital
Mar 2021
Decision
284d
Days
Class 2
Risk

About This 510(k) Submission

K201452 is an FDA 510(k) clearance for the Groshong NXT PICC Catheter, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on March 12, 2021, 284 days after receiving the submission on June 1, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K201452 FDA.gov
FDA Decision Cleared SESE
Date Received June 01, 2020
Decision Date March 12, 2021
Days to Decision 284 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5970

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