Cleared Traditional

K143073 - Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface

K143073 is an FDA 510(k) clearance for Affinity NT Oxygenator, manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DTZ cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K143073 · Medtronic, Inc. · Cardiovascular device
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Mar 2015
Decision
149d
Days
Class 2
Risk

K143073 is an FDA 510(k) clearance for the Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affi.... Classified as Oxygenator, Cardiopulmonary Bypass (product code DTZ), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 25, 2015 after a review of 149 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4350 - 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, Inc. devices

FDA 510(k) Submission Details - K143073

510(k) Number K143073 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 27, 2014
Decision Date March 25, 2015
Days to Decision 149 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
24d slower than avg
Panel avg: 125d · This submission: 149d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTZ Device Classification - Class 2, Special Controls

Product Code DTZ Oxygenator, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4350
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 - DTZ Oxygenator, Cardiopulmonary Bypass

All 220
Devices cleared under the same product code (DTZ) and FDA review panel - the closest regulatory comparables to K143073.
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
K151389 · Terumo Cardiovascular Systems Corporation · Oct 2015
EOS PMP, EOS PMP Integrated
K150489 · Sorin Group Italia S.R.L. · Jun 2015
QUADROX-i Adult/Small Adult Oxygenators
K150267 · Maquet Cardiopulmonary, AG · May 2015
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda BioActive Surface
K142784 · Medtronic, Inc. · Oct 2014
TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
K140774 · Terumo Cardiovascular Systems Corporation · Jun 2014
QUADROX-I, QUADROX-ID, QUADROX-IR OXYGENATORS
K132829 · Maquet Cardiopulmonary, AG · Oct 2013