Cleared Traditional

DIDECO-SHILEY UNIVERSAL Y

K894294 · Shiley, Inc. · Anesthesiology
Aug 1989
Decision
53d
Days
Class 2
Risk

About This 510(k) Submission

K894294 is an FDA 510(k) clearance for the DIDECO-SHILEY UNIVERSAL Y, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on August 15, 1989, 53 days after receiving the submission on June 23, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number K894294 FDA.gov
FDA Decision Cleared SESE
Date Received June 23, 1989
Decision Date August 15, 1989
Days to Decision 53 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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