# K213666: NuCath Wedge Pressure Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Pfm Medical, Inc.
- Decided: Oct 6, 2022 after 318 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K864943 (1987). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K864943: Numed Balloon Wedge Pressure Catheter, NuMED, Inc. (1987) Summary page 4.

## Indications for use
The NuCath™ Wedge Pressure Catheter is indicated for measuring pressure in the right heart (including central venous pressure, right ventricle pressure, pulmonary artery pressure, and pulmonary artery wedge pressure).

Source page: https://510kreport.com/device/K213666
Methodology: https://510kreport.com/methodology