# K915726: Pulmonary Artery Flow-Directed Thermodilution Cath

- Pathway: 510(k) (Traditional)
- Applicant: Baxter Healthcare Corp
- Decided: Sep 21, 1992 after 276 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Recalls of this device
- May 11, 2012 · Class II · Z-2193-2012: 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.
- May 11, 2012 · Class II · Z-2194-2012: 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.

Source page: https://510kreport.com/device/K915726
Methodology: https://510kreport.com/methodology