# K152784: Pacel Bipolar Pacing Catheters

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Oct 22, 2015 after 27 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
Longest line of descent: 1 generation back to K875059 (1988). 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)
- K875059: Disposable Bipolar Temporary Pacing Electrode, Daig Corp. (1988) Summary page 4.

## Indications for use
The St. Jude Medical Pacel™ Bipolar Pacing Catheters are intended for use in the intracardiac pacing and/or ECG recording.

Source page: https://510kreport.com/device/K152784
Methodology: https://510kreport.com/methodology