Cleared Traditional

K860702 - SARNS FILTERED CARDIOTOMY RESERVOIR

K860702 is an FDA 510(k) clearance for SARNS FILTERED CARDIOTOMY RESERVOIR, manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code DTP cleared through the Traditional 510(k) pathway after a 92-day FDA review.

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

FDA 510(k) Submission Details - K860702

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
Combination Product No
PCCP Authorized No
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.

DTP Device Classification - Class 2, Special Controls

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 32
Devices cleared under the same product code (DTP) and FDA review panel - the closest regulatory comparables to K860702.
CAP-35 AND CAP35 F
K874924 · Gish Biomedical, Inc. · Jan 1988
CARDIOTOMY/MEDIASTINAL AUTO. RESERVOIR CATR-3500
K872167 · American Bentley · Sep 1987
THORASTAT ATR-XXXX
K870792 · Gish Biomedical, Inc. · Apr 1987
MEDIASTINAL AUTOTRANSFUSION SYSTEM
K860775 · Cardio Metrics, Inc. · May 1986
MODIFIED MODEL SC4000(F) CARDIOTOMY RESERVOIR
K855049 · Scimed Life Systems, Inc. · Feb 1986
SHILEY 3L CARDIOTOMY RESERVOIR
K853503 · Shiley, Inc. · Nov 1985