Cleared Traditional

SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY.

K901624 · Shiley, Inc. · Cardiovascular
Jul 1990
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K901624 is an FDA 510(k) clearance for the SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY., a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on July 3, 1990, 85 days after receiving the submission on April 9, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K901624 FDA.gov
FDA Decision Cleared SESE
Date Received April 09, 1990
Decision Date July 03, 1990
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DTZ — Oxygenator, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4350

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