Cleared Traditional

K162958 - MYOtherm XP Cardioplegia Delivery Syste...

Also marketed or referenced as:
MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge MYOtherm XP Cardioplegia Delivery System MYOtherm XP Cardioplegia Delivery System with Bridge

K162958 is an FDA 510(k) clearance for MYOtherm XP Cardioplegia Delivery Syste..., manufactured by Medtronic, Inc.. The device is a Class 2 Cardiovascular device with product code DTR cleared through the Traditional 510(k) pathway after a 100-day FDA review.

K162958 · Medtronic, Inc. · Cardiovascular device
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Feb 2017
Decision
100d
Days
Class 2
Risk

K162958 is an FDA 510(k) clearance for the MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface. Classified as Heat-exchanger, Cardiopulmonary Bypass (product code DTR), Class II - Special Controls.

Submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 1, 2017 after a review of 100 days - within the typical 510(k) review window.

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, Inc. devices

FDA 510(k) Submission Details - K162958

510(k) Number K162958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 24, 2016
Decision Date February 01, 2017
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
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 83
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K162958.
MPS 3 Myocardial Protection System
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MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)
K162774 · Medtronic, Inc. · Feb 2017
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30
K090555 · Maquet Cardiopulmonary, AG · Dec 2009
GISH VISION BLOOD CARDIOPLEGIA WITH HA COATING
K081838 · Gish Biomedical, Inc. · Jan 2009
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30
K072583 · Maquet Cardiopulmonary, AG · Apr 2008