# K963248: Flow Directed Thermodilution/Infusion Balloon Catheter (575-110P)

- Pathway: 510(k) (Traditional)
- Applicant: J-Lloyd Medical, Inc.
- Decided: Feb 3, 1997 after 168 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.
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. The FDA summary names its predicate without a number.
- (no number) Nova Medical Specialties, Inc. design: named in the summary without a submission number

## Indications for use
provide a means to obtain right heart pressure readings from various parts of the right heart and cardiac output

Source page: https://510kreport.com/device/K963248
Methodology: https://510kreport.com/methodology