Cleared Special

POWERPICC

K053501 · Bard Access Systems, Inc. · General Hospital
Jan 2006
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K053501 is an FDA 510(k) clearance for the POWERPICC, 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 City, US). The FDA issued a Cleared decision on January 13, 2006, 28 days after receiving the submission on December 16, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K053501 FDA.gov
FDA Decision Cleared SESE
Date Received December 16, 2005
Decision Date January 13, 2006
Days to Decision 28 days
Submission Type Special
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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