Cleared Traditional

MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface (K162958) - FDA 510(k) Clearance

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

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 35
Devices cleared under the same product code (DTR) and FDA review panel - the closest regulatory comparables to K162958.
MPS 3 Myocardial Protection System
K200438 · Quest Medical, Inc. · Jun 2020
MPS2 Myocardial Protection System Console
K173716 · Quest Medical, Inc. · Oct 2018
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
CBMYOTHERM XP CARDIOPLEGIA DELIVERY SYSTEM WITH CARMEDA BIOACTIVE SURFACE, MODELS CB41 AND CB41-B
K003724 · Medtronic Vascular · Dec 2000
CAPIOX CARDIOPLEGIA
K982467 · Terumo Medical Corp. · Jun 1999
CARMEDA COATED CARDIOTHERM BLOOD CARDIOPLEGIA SYSTEMS (CBCTXXX SERIES AND CBCTXXXBR SERIES)
K973475 · Medtronic Vascular · Nov 1997