# K061527: Card 43 Cardiotomy Reservoir with Phosphorylcholine Coating

- Pathway: 510(k) (Special)
- Applicant: Sorin Group Italia S.R.L.
- Decided: Jun 27, 2006 after 25 days
- Product code: DTN (Reservoir, Blood, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K922933 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022450: Integrated Unit: Synthesis: Adult Membrane Oxygenator with Integrated Arterial Filter and Hardhshell Venous/Cardiotomy, Dideco S.P.A. (2002) Summary page 1.

## Indications for use
The CARD 43 is a cardiotomy reservoir specifically designed for cardiovascular procedures requiring cardiopulmonary by-pass. It defoams, filters and stores the blood from the operating field through thoracic, intracardiac and general suction. CARD 43 can be used postoperatively for chest drainage. The Card 43 should not be used longer than 6 hours. Contact with blood for longer periods is not advised.

Source page: https://510kreport.com/device/K061527
Methodology: https://510kreport.com/methodology