Cleared Traditional

SHILEY PERFUSION TUBING SETS

K920594 · Shiley, Inc. · Cardiovascular
Mar 1993
Decision
401d
Days
Class 2
Risk

About This 510(k) Submission

K920594 is an FDA 510(k) clearance for the SHILEY PERFUSION TUBING SETS, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on March 18, 1993, 401 days after receiving the submission on February 11, 1992. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4260.

Submission Details

510(k) Number K920594 FDA.gov
FDA Decision Cleared SESE
Date Received February 11, 1992
Decision Date March 18, 1993
Days to Decision 401 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4260

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