Cleared Traditional

K133598 - CARDIOHELP SYSTEM

K133598 is an FDA 510(k) clearance for CARDIOHELP SYSTEM, manufactured by Maquet Cardiopulmonary, AG. The device is a Class 2 Cardiovascular device with product code DTQ cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K133598 · Maquet Cardiopulmonary, AG · Cardiovascular device
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May 2014
Decision
180d
Days
Class 2
Risk

K133598 is an FDA 510(k) clearance for the CARDIOHELP SYSTEM. Classified as Console, Heart-lung Machine, Cardiopulmonary Bypass (product code DTQ), Class II - Special Controls.

Submitted by Maquet Cardiopulmonary, AG (Wayne, US). The FDA issued a Cleared decision on May 21, 2014 after a review of 180 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4220 - 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 Maquet Cardiopulmonary, AG devices

FDA 510(k) Submission Details - K133598

510(k) Number K133598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2013
Decision Date May 21, 2014
Days to Decision 180 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
55d slower than avg
Panel avg: 125d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTQ Device Classification - Class 2, Special Controls

Product Code DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4220
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 - DTQ Console, Heart-lung Machine, Cardiopulmonary Bypass

All 38
Devices cleared under the same product code (DTQ) and FDA review panel - the closest regulatory comparables to K133598.
Advanced Perfusion System 1
K163531 · Terumo Cardiovascular Systems Corporation · Jun 2017
Advanced Perfusion System 1
K153376 · Terumo Cardiovascular Systems Corporation · Dec 2015
Advanced Perfusion System 1
K151349 · Terumo Cardiovascular Systems Corporation · Aug 2015
ADVANCED PERFUSION SYSTEM 1
K131041 · Terumo Cardiovascular Systems Corp. · Feb 2014
CARDIOHELP SYSTEM
K102726 · Maquet Cardiopulmonary, AG · Apr 2011
SORIN C5 SYSTEM
K103762 · Sorin Group Deutschland GmbH · Jan 2011