Cleared Traditional

K953838 - MYOCARDIAL PROTECTION SYSTEM

K953838 is an FDA 510(k) clearance for MYOCARDIAL PROTECTION SYSTEM, manufactured by Quest Medical, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 203-day FDA review.

K953838 · Quest Medical, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1996
Decision
203d
Days
Class 2
Risk

K953838 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 Quest Medical, Inc. (Allen, US). The FDA issued a Cleared decision on March 6, 1996 after a review of 203 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 Quest Medical, Inc. devices

FDA 510(k) Submission Details - K953838

510(k) Number K953838 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 16, 1995
Decision Date March 06, 1996
Days to Decision 203 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
78d slower than avg
Panel avg: 125d · This submission: 203d
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 K953838.
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
K973475 · Medtronic Vascular · Nov 1997
VISION CARDIOPLEGIA DELIVERY SYSTEM
K964571 · Lifestream Int'L, Inc. · Aug 1997
S3 CARDIOPLEGIA CONTROL
K962320 · Stoeckert Instrumente · Jan 1997
SINGLE PASS BLOOD CARDIOPLEGIA SPBC SYSTEM COMPONENTS
K944219 · Gish Biomedical, Inc. · Jun 1995
HEAT EXCHANGER MODIFICATION FOR DUO AND OPTIMA
K944267 · Cobe Cardiovascular, Inc. · Apr 1995
ELECTROMEDICS BLOOD HEAT EXCHANGER
K934355 · Electromedics, Inc. · Dec 1993