Cleared Traditional

PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT

K141965 · Care Fusion · Anesthesiology
Jul 2015
Decision
346d
Days
Class 2
Risk

About This 510(k) Submission

K141965 is an FDA 510(k) clearance for the PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, a Apparatus, Suction, Patient Care (Class II — Special Controls, product code DWM), submitted by Care Fusion (Vernon Hills, US). The FDA issued a Cleared decision on July 2, 2015, 346 days after receiving the submission on July 21, 2014. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.5050.

Submission Details

510(k) Number K141965 FDA.gov
FDA Decision Cleared SESE
Date Received July 21, 2014
Decision Date July 02, 2015
Days to Decision 346 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DWM — Apparatus, Suction, Patient Care
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5050

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