MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)— 510(k) K162774

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K162774 for MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System), Substantially Equivalent on 2017-02-10. Applicant: Medtronic, Inc..

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DTR
Advisory panel: Cardiovascular
Date received: 2016-10-03
Decision date: 2017-02-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mounds View, MN, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTR

product code DTR

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.