# K162774: MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface (Bridge System)

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Feb 10, 2017 after 130 days
- Product code: DTR (Heat-Exchanger, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K003724 (2000). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K003724: Cbmyotherm XP Cardioplegia Delivery System with Carmeda Bioactive Surface, Models CB41 and CB41-B, Medtronic Vascular (2000) Summary page 4.

## Most influential descendants
- K240190: MYOtherm XP Cardioplegia Delivery System with Cortiva BioActive Surface, MYOtherm XP Cardioplegia Delivery System Uncoated (2024), 0 descendants of its own

## Indications for use
The MYOtherm XP with Cortiva bioactive surface is a device intended for the mixing, warming/cooling and delivery of oxygenated blood/cardioplegia solution in a predetermined ratio during routine cardiopulmonary bypass (CPB) procedures up to 6 hours in duration. Blood/cardioplegia solution is delivered to the patient through the cardioplegia delivery system and appropriate cannula by the operation of a single occlusive roller pump.

Source page: https://510kreport.com/device/K162774
Methodology: https://510kreport.com/methodology