Cleared Traditional

K914742 - MYOCARD PROTECT SYST W/BLOOD CARDIO HEA...

K914742 is the FDA 510(k) clearance for MYOCARD PROTECT SYST W/BLOOD CARDIO HEA... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DTR) cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K914742 · Medtronic Vascular · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Dec 1991
Decision
84d
Days
Class 2
Risk

K914742 is an FDA 510(k) clearance for the MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Medtronic Vascular (Anaheim, US). The FDA issued a Cleared decision on December 4, 1991 after a review of 84 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 Medtronic Vascular devices

Submission Details

510(k) Number K914742 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 1991
Decision Date December 04, 1991
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
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 K914742.
CONDUCER HEAT EXCHANGER
K923311 · 3M Health Care, Sarns · Sep 1992
LANCASTER COOLING JACKET, CAT. CODE #13500/13501
K913077 · Dlp, Inc. · Jan 1992
CPS-PLUS CARDIOPLEGIA SYSTEMS, CAT# CPS-X SERIES
K913691 · Gish Biomedical, Inc. · Dec 1991
MYOCARDIAL PROTECTION SYSTEM
K905500 · Medtronic Vascular · Jun 1991
BCD ADVANCED
K910923 · Shiley, Inc. · Apr 1991
SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
K896807 · Gish Biomedical, Inc. · Jul 1990