Cleared Traditional

K897039 - SARNS MINIPRIME CARDIOPLEGIA SET W/COND...

K897039 is the FDA 510(k) clearance for SARNS MINIPRIME CARDIOPLEGIA SET W/COND... by 3M Company. It is a Class 2 Cardiovascular device (product code DTR) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K897039 · 3M Company · Cardiovascular device
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Mar 1990
Decision
88d
Days
Class 2
Risk

K897039 is an FDA 510(k) clearance for the SARNS MINIPRIME CARDIOPLEGIA SET W/CONDUCER(TM). Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by 3M Company (Ann Arbor, US). The FDA issued a Cleared decision on March 16, 1990 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all 3M Company devices

Submission Details

510(k) Number K897039 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 18, 1989
Decision Date March 16, 1990
Days to Decision 88 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
37d faster than avg
Panel avg: 125d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 76
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K897039.
SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
K896807 · Gish Biomedical, Inc. · Jul 1990
EXTRACORPOREAL HEAT EXCHANGER HE SERIES
K896020 · Gish Biomedical, Inc. · May 1990
MODIFIED MP-4 CARDIOPLEGIA DELIVERY SYSTEM W/CONDU
K900640 · 3M Company · Apr 1990
SCIMED ECMOTHERM(TM) HEAT EXCHANGER
K884560 · Scimed Life Systems, Inc. · Apr 1989
SARNS MP4 CARDIOPLEGIA DELIVERY SYSTEM
K883071 · 3M Health Care, Sarns · Dec 1988
BASIC HEATER-COOLER UNIT, 115/100V 16-02-20
K883330 · Shiley, Inc. · Sep 1988