# K083794: Mecc Set with Bioline Coating

- Pathway: 510(k) (Traditional)
- Applicant: Maquet Cardiopulmonary, AG
- Decided: Apr 21, 2009 after 120 days
- Product code: KFM (Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type)
- Device class: 2
- Regulation: 21 CFR 870.4360
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K932252 (1993). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K080592: HLM Tubing Set with Bioline Coating, Maquet Cardiopulmonary, AG (2008) Summary page 5.
- K023132: Jostra Mecc System, Jostra AG (2002) Summary page 5.

## Indications for use
The MECC Set with Bioline Coating is a prescription device that uses a method other than revolving rollers to pump the blood through an extracorporeal circuit for periods lasting less than 6 hours for the purpose of providing either: (i) Full or partial cardiopulmonary bypass (i.e., circuit includes an oxygenator) during open surgical procedures on the heart or great vessels; or (ii) Temporary circulatory bypass for diversion of flow around a planned disruption of the circulatory pathway necessary for open surgical procedures on the aorta or vena cava.

Source page: https://510kreport.com/device/K083794
Methodology: https://510kreport.com/methodology