# K811411: Swan-Ganz Heparin Coated, Etc. Catheter

- Pathway: 510(k) (Traditional)
- Applicant: American Edwards Laboratories
- Decided: Jun 12, 1981 after 24 days
- Product code: KRB (Probe, Thermodilution)
- Device class: 2
- Regulation: 21 CFR 870.1915
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K961245: Heartport Endopulmonary Vent (1996), 1 descendant of its own
- K962858: Heartport Endovascular Cardiopulmonary Bypass System Antegrade Sytem (Catalog Number Ecpb-a) Antegrade/Retrograde System (1996), 0 descendants of its own

Source page: https://510kreport.com/device/K811411
Methodology: https://510kreport.com/methodology