# K896978: Closed Chest Support Circuit W/Bio-Active Surface

- Pathway: 510(k) (Traditional)
- Applicant: Medtronic Vascular
- Decided: Feb 28, 1990 after 77 days
- Product code: DTZ (Oxygenator, Cardiopulmonary Bypass)
- Device class: 2
- Regulation: 21 CFR 870.4350
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
49 later devices descend from it; 1 cites it directly.
4 of 50 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K973011: BPX80 Bio-Pump (BPX80) (1998), 48 descendants of its own
- K020271: Levitronix Centrimag Extracorporeal Blood Pumping System, Model L-100 (2003), 21 descendants of its own
- K991783: AB-180 XC System, Model AB-180XC (2000), 13 descendants of its own
- K053630: Levitronix Centrimag Primary Console (2006), 11 descendants of its own
- K081221: Levitronix Centrimag Primary Console, Thoratec Centrimag Primary Console (2008), 10 descendants of its own

## Recalls of this device
- Mar 25, 2005 · Not classified · Z-0808-05: Some warehouse inventory of Custom Pack product bags were found with ruptured seals. The seals were partially opened in the center of the bag's Tyvek edge. Since this bag is used to enclose and seal t

Source page: https://510kreport.com/device/K896978
Methodology: https://510kreport.com/methodology