Cleared Traditional

K893711 - DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOM...

K893711 is an FDA 510(k) clearance for DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOM..., manufactured by Shiley, Inc.. The device is a Class 2 Cardiovascular device with product code DTN cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K893711 · Shiley, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K893711

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
Combination Product No
PCCP Authorized No
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.

DTN Device Classification - Class 2, Special Controls

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 134
Devices cleared under the same product code (DTN) and FDA review panel - the closest regulatory comparables to K893711.
SOFTSHELL VENOUS RESERVOIR
K904040 · C.R. Bard, Inc. · Dec 1990
CAPIOX HARDSHELL VENOUS RESERVOIR
K894664 · Terumo Medical Corp. · Apr 1990
UNIVOX-IC
K895356 · Baxter Healthcare Corp · Mar 1990
VENOUS RESERVOIR BAG MODEL NO. BMR-800 W/HEPARIN
K896414 · Baxter Healthcare Corp · Jan 1990
CMS VRB-1200
K895076 · Cobe Laboratories, Inc. · Nov 1989
DIDECO-SHILEY AUTOTRANSFUSION CARDIOTOMY RESERVOIR
K884872 · Shiley, Inc. · Jan 1989