Cleared Traditional

STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR

K900797 · Shiley, Inc. · Cardiovascular
May 1990
Decision
79d
Days
Class 2
Risk

About This 510(k) Submission

K900797 is an FDA 510(k) clearance for the STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR, a Gauge, Pressure, Coronary, Cardiopulmonary Bypass (Class II — Special Controls, product code DXS), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on May 10, 1990, 79 days after receiving the submission on February 20, 1990. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4310.

Submission Details

510(k) Number K900797 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 1990
Decision Date May 10, 1990
Days to Decision 79 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary —

Device Classification

Product Code DXS — Gauge, Pressure, Coronary, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4310

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