Cleared Special

MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated

K240190 · Medtronic · Cardiovascular
Feb 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K240190 is an FDA 510(k) clearance for the MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated, a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Medtronic (Mounds View, US). The FDA issued a Cleared decision on February 23, 2024, 30 days after receiving the submission on January 24, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4240.

Submission Details

510(k) Number K240190 FDA.gov
FDA Decision Cleared SESE
Date Received January 24, 2024
Decision Date February 23, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTR — Heat-exchanger, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4240

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