Cleared Traditional

SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR

K894630 · Shiley, Inc. · Cardiovascular
Oct 1989
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K894630 is an FDA 510(k) clearance for the SHILEY PLEXUS(TM) ADULT HOLLOW FIBER OXYGENATOR, a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on October 20, 1989, 88 days after receiving the submission on July 24, 1989. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K894630 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1989
Decision Date October 20, 1989
Days to Decision 88 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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