Cleared Traditional

K901249 - PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR
(FDA 510(k) Clearance)

K901249 · Shiley, Inc. · Cardiovascular
Jun 1990
Decision
87d
Days
Class 2
Risk

K901249 is an FDA 510(k) clearance for the PLEXUS 3.5(TM) PEDIATRIC 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 June 11, 1990, 87 days after receiving the submission on March 16, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K901249 FDA.gov
FDA Decision Cleared SESE
Date Received March 16, 1990
Decision Date June 11, 1990
Days to Decision 87 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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