# K963073: Harmac Bipolar Temporary Pacing Catheter with Stylet

- Pathway: 510(k) (Traditional)
- Applicant: Harmac Medical Products, Inc.
- Decided: Aug 14, 1997 after 412 days
- Product code: LDF (Electrode, Pacemaker, Temporary)
- Device class: 2
- Regulation: 21 CFR 870.3680
- 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 Bipolar Temporary Pacing Catheter with Stylet is indicated for use in temporary transvenous cardiac pacing when impulse formation or conduction is impaired.

Source page: https://510kreport.com/device/K963073
Methodology: https://510kreport.com/methodology