Cleared Traditional

K800377 - CARDIOPLEGIA DELIVERY SYSTEM

K800377 is the FDA 510(k) clearance for CARDIOPLEGIA DELIVERY SYSTEM by 3M Health Care, Sarns. It is a Class 2 Cardiovascular device (product code DTR) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K800377 · 3M Health Care, Sarns · Cardiovascular device
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Mar 1980
Decision
27d
Days
Class 2
Risk

K800377 is an FDA 510(k) clearance for the CARDIOPLEGIA DELIVERY SYSTEM. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by 3M Health Care, Sarns (Mchenry, US). The FDA issued a Cleared decision on March 19, 1980 after a review of 27 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 Health Care, Sarns devices

Submission Details

510(k) Number K800377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 21, 1980
Decision Date March 19, 1980
Days to Decision 27 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
98d faster than avg
Panel avg: 125d · This submission: 27d
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 78
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K800377.
BUCKBERG-SHILEY BLOOD CARDIOPLEGIC SPL.
K802879 · Shiley, Inc. · Dec 1980
CARDIOPLEGIA COOLING SYST. CCAS-2
K802848 · Bentley Laboratories, Inc. · Dec 1980
TOPICAL COOLING DEV. TCD. #27-999
K800717 · Cobe Laboratories, Inc. · Apr 1980
MINIPRIME HYPOTHERMIC HEAT EXCHANGER
K791430 · Travenol Laboratories, S.A. · Aug 1979
PAD, COOLING #27-999
K781764 · Cobe Laboratories, Inc. · Dec 1978
HEAT EXCHANGER, DISP., OMNITHERM
K772117 · Scimed Life Systems, Inc. · Mar 1978