# K812563: Swan-Ganz & Edslab Heparin Coated Cath.

- Pathway: 510(k) (Traditional)
- Applicant: American Edwards Laboratories
- Decided: Sep 25, 1981 after 17 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device 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.

## Recalls of this device
- May 11, 2012 · Class II · Z-2195-2012: The device is being recalled because the firm received multiple complaints related to passage of a J-tip guidewire when inserted through the distal lumen hub of the catheter.
- Nov 27, 2006 · Not classified · Z-0338-2007: Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 

Source page: https://510kreport.com/device/K812563
Methodology: https://510kreport.com/methodology