Cleared Traditional

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

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K893711 · Shiley, Inc. · Cardiovascular device
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Feb 1990
Decision
286d
Days
Class 2
Risk

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

Submitted by Shiley, Inc. (Irvine, US). The FDA issued a Cleared decision on February 28, 1990 after a review of 286 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4400 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shiley, Inc. devices

Submission Details

510(k) Number K893711 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 1989
Decision Date February 28, 1990
Days to Decision 286 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
161d slower than avg
Panel avg: 125d · This submission: 286d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTN Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DTN Reservoir, Blood, Cardiopulmonary Bypass

All 168
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K893711.
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