Cleared Traditional

MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM

K894668 · Shiley, Inc. · Anesthesiology
Oct 1989
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K894668 is an FDA 510(k) clearance for the MODIFIED SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on October 20, 1989, 87 days after receiving the submission on July 25, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K894668 FDA.gov
FDA Decision Cleared SESE
Date Received July 25, 1989
Decision Date October 20, 1989
Days to Decision 87 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code CAC — Apparatus, Autotransfusion
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5830

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