Cleared Traditional

K883071 - SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM

K883071 is an FDA 510(k) clearance for SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM, manufactured by 3M Health Care, Sarns. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 138-day FDA review.

K883071 · 3M Health Care, Sarns · Cardiovascular device
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Dec 1988
Decision
138d
Days
Class 2
Risk

K883071 is an FDA 510(k) clearance for the SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Ann Arbor, US). The FDA issued a Cleared decision on December 5, 1988 after a review of 138 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4240 - 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 - K883071

510(k) Number K883071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1988
Decision Date December 05, 1988
Days to Decision 138 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
13d slower than avg
Panel avg: 125d · This submission: 138d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTR Device Classification - Class 2, Special Controls

Product Code DTR Heat-exchanger, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4240
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 - DTR Heat-exchanger, Cardiopulmonary Bypass

All 78
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K883071.
MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
K900640 · 3M Company · Apr 1990
SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM)
K897039 · 3M Company · Mar 1990
SCIMED ECMOTHERM(TM) HEAT EXCHANGER
K884560 · Scimed Life Systems, Inc. · Apr 1989
BASIC HEATER-COOLER UNIT, 115/100V 16-02-20
K883330 · Shiley, Inc. · Sep 1988
BASIC HEATER-COOLER UNIT W/MAST, 115/110V 16-21-10
K883331 · Shiley, Inc. · Sep 1988
MAST FOR BASIC HEATER-COOLER UNIT 16-09-00
K883332 · Shiley, Inc. · Sep 1988