Cleared Traditional

K051672 - POWERPICC
(FDA 510(k) Clearance)

K051672 · Bard Access Systems, Inc. · General Hospital
Nov 2005
Decision
153d
Days
Class 2
Risk

K051672 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 November 23, 2005, 153 days after receiving the submission on June 23, 2005. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5970.

Submission Details

510(k) Number K051672 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 2005
Decision Date November 23, 2005
Days to Decision 153 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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