# K963335: Harmac Balloon Wedge Pressure Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Harmac Medical Products, Inc.
- Decided: Oct 16, 1997 after 475 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
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’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The Balloon Wedge Pressure catheter is indicated for use in sampling blood for oxygen levels and measuring pressure in the right heart (including central venous pressure, right ventricular pressure, pulmonary artery pressure and pulmonary artery wedge pressure). In the case of anatomical cardiac defect or situations requiring left transseptal access, this catheter may be used in any chamber which can be entered from the right heart.

Source page: https://510kreport.com/device/K963335
Methodology: https://510kreport.com/methodology