Cleared Traditional

BD PowerPiCC Catheter

K210264 · Bard Access Systems, Inc. · General Hospital
Jul 2021
Decision
179d
Days
Class 2
Risk

About This 510(k) Submission

K210264 is an FDA 510(k) clearance for the BD PowerPiCC Catheter, a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II — Special Controls, product code LJS), submitted by Bard Access Systems, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on July 30, 2021, 179 days after receiving the submission on February 1, 2021. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K210264 FDA.gov
FDA Decision Cleared SESE
Date Received February 01, 2021
Decision Date July 30, 2021
Days to Decision 179 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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