Cleared Special

DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER

K040184 · Cobe Cardiovascular, Inc. · Cardiovascular
Feb 2004
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K040184 is an FDA 510(k) clearance for the DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on February 26, 2004, 31 days after receiving the submission on January 26, 2004. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4260.

Submission Details

510(k) Number K040184 FDA.gov
FDA Decision Cleared SESE
Date Received January 26, 2004
Decision Date February 26, 2004
Days to Decision 31 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4260

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