Cleared Traditional

K905500 - MYOCARDIAL PROTECTION SYSTEM

K905500 is an FDA 510(k) clearance for MYOCARDIAL PROTECTION SYSTEM, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 185-day FDA review.

K905500 · Medtronic Vascular · Cardiovascular device
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Jun 1991
Decision
185d
Days
Class 2
Risk

K905500 is an FDA 510(k) clearance for the MYOCARDIAL PROTECTION SYSTEM. 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 June 10, 1991 after a review of 185 days - an extended review 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: 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 Medtronic Vascular devices

FDA 510(k) Submission Details - K905500

510(k) Number K905500 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 07, 1990
Decision Date June 10, 1991
Days to Decision 185 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
60d slower than avg
Panel avg: 125d · This submission: 185d
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 84
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K905500.
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
MYOCARD PROTECT SYST W/BLOOD CARDIO HEAT EXC/MODIF
K914742 · Medtronic Vascular · Dec 1991
BCD ADVANCED
K910923 · Shiley, Inc. · Apr 1991
SPBC SERIES SINGLE PASS BLOOD CARDIOPLEGIA SYSTEM
K896807 · Gish Biomedical, Inc. · Jul 1990
EXTRACORPOREAL HEAT EXCHANGER HE SERIES
K896020 · Gish Biomedical, Inc. · May 1990