# K162958: MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface; MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface with Bridge; MYOtherm XP Cardioplegia Delivery System; MYOtherm XP Cardioplegia Delivery System with Bridge

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic, Inc.
- Decided: Feb 1, 2017 after 100 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: 2 generations back to K971105 (1997). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011864: Trillium Myotherm XP Cardioplegia Delivery System, Models 41, 41-B, Medtronic Vascular (2001) Summary page 5.
- K971105: Myotherm (TM) XP Cardioplegia Delivery System, Avecor Cardiovascular, Inc. (1997) Summary page 5.

## 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
MYOtherm XP Cardioplegia Delivery System Models XP41 and XP41B (uncoated) - The MYOtherm XP cardioplegia delivery system 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. MYOtherm XP Cardioplegia Delivery System with Trillium Biosurface Models XP41T and XP41BT - The MYOtherm XP system with Trillium biosurface 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/K162958
Methodology: https://510kreport.com/methodology