# K962829: Harmac Balloon Angiographic 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 Angiographic catheter is indicated for use in right heart catheterization for cardiac angiography, and measurement of the right heart and pulmonary artery pressures. It can be used to inject radiopaque media and measure pressures in any chamber or vessel that can be entered from the right heart.

Source page: https://510kreport.com/device/K962829
Methodology: https://510kreport.com/methodology