# K161873: Pacel Flow Directed Pacing Catheter

- Pathway: 510(k) (Traditional)
- Applicant: St Jude Medical
- Decided: Nov 22, 2016 after 138 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 K914185 (1992). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K914185: Pacel (TM) Flow Directed Pacing Catheter, Daig Corp. (1992) Summary page 4.

## Most influential descendants
- K242863: Bioptimal Bipolar Pacing Catheter (2025), 0 descendants of its own

## Indications for use
Pacel™ Flow Directed Pacing Catheters are indicated for use in temporary, transvenous, right ventricular pacing.

Source page: https://510kreport.com/device/K161873
Methodology: https://510kreport.com/methodology