# K802288: Swan Ganz Catheter Placement Kit

- Pathway: 510(k) (Traditional)
- Applicant: Stanco Medical, Inc.
- Decided: Nov 20, 1980 after 62 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
22 later devices descend from it; 1 cites it directly.
4 of 23 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
- K012274: Medtronic Physio-Control Lifepak 20 Defibrillator/Monitor/Pacemaker (2002), 21 descendants of its own
- K033275: Lifepak 12, 20, 500, CR Plus (2003), 20 descendants of its own
- K040775: Lifepak 12 (2004), 10 descendants of its own
- K041459: Lifepak 12 Defibrillator/Monitor (2004), 9 descendants of its own
- K063510: Lifepak 12 Defibrillator/Monitor (2007), 7 descendants of its own

Source page: https://510kreport.com/device/K802288
Methodology: https://510kreport.com/methodology