Cleared Traditional

SARNS FILTERED CARDIOTOMY RESERVOIR (K860702) - FDA 510(k) Clearance

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

K860702 · 3M Health Care, Sarns · Cardiovascular device
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May 1986
Decision
92d
Days
Class 2
Risk

K860702 is an FDA 510(k) clearance for the SARNS FILTERED CARDIOTOMY RESERVOIR. Classified as Defoamer, Cardiopulmonary Bypass (product code DTP), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on May 28, 1986 after a review of 92 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4230 - 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 3M Health Care, Sarns devices

Submission Details

510(k) Number K860702 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1986
Decision Date May 28, 1986
Days to Decision 92 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
33d faster than avg
Panel avg: 125d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DTP Defoamer, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4230
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 - DTP Defoamer, Cardiopulmonary Bypass

All 12
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K860702.
MODEL 5866-46 SLEEVE KIT
K910568 · Medtronic Vascular · Apr 1991
BARD FILTERED CARDIOTOMY RESERVOIR
K902856 · C.R. Bard, Inc. · Sep 1990
MCR4000 & MCR4000F CARDIOTOMY RESERVOIR
K902355 · Medtronic Vascular · Aug 1990
SHILEY 3L CARDIOTOMY RESERVOIR
K853503 · Shiley, Inc. · Nov 1985
SHILEY 3L CARDF PLUS
K832811 · Shiley, Inc. · Sep 1983
CARDF
K823731 · Shiley, Inc. · Jan 1983