# K112323: Cardia-Cath

- Pathway: 510(k) (Special)
- Applicant: Millar Instruments, Inc.
- Decided: Oct 18, 2011 after 67 days
- Product code: DXO (Transducer, Pressure, Catheter Tip)
- Device class: 2
- Regulation: 21 CFR 870.2870
- 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) Millar legally marketed device, model SPC-550: named in the summary without a submission number

## Indications for use
Monitoring combined pressure and electrical impedance (volume) in the cardiovascular system

Source page: https://510kreport.com/device/K112323
Methodology: https://510kreport.com/methodology