# K832957: Flow-Directed Heparin Coated Thermodil

- Pathway: 510(k) (Traditional)
- Applicant: Sorensen Research
- Decided: Sep 29, 1983 after 29 days
- Product code: DYG (Catheter, Flow Directed)
- Device class: 2
- Regulation: 21 CFR 870.1240
- 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.
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
- Nov 19, 2003 · Not classified · Z-0305-04: Thermodilution catheters have a potential for ruptured lumens within the catheter.

Source page: https://510kreport.com/device/K832957
Methodology: https://510kreport.com/methodology