Cleared Traditional

K893711 - DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
(FDA 510(k) Clearance)

K893711 · Shiley, Inc. · Cardiovascular

Feb 1990

Decision

286d

Days

Class 2

Risk

K893711 is an FDA 510(k) clearance for the DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR. This device is classified as a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN).

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on February 28, 1990, 286 days after receiving the submission on May 18, 1989.

This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number	K893711 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 18, 1989
Decision Date	February 28, 1990
Days to Decision	286 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	—