# K813521: Transluminal Bipolar Pacing Probe

- Pathway: 510(k) (Traditional)
- Applicant: American Edwards Laboratories
- Decided: Mar 15, 1982 after 89 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.
2 later devices descend 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K152633: Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe (2015), 1 descendant of its own
- K233983: Swan-Ganz Pacing Probe and Catheters; Swan-Ganz Bipolar Pacing Catheter (D97120F5); Swan-Ganz Bipolar Pacing Catheter (D97130F5); Swan-Ganz Pacing Thermodilution TD Catheter (D200F7); Chandler Transluminal V-Pacing Probe (D98100) (2024), 0 descendants of its own

Source page: https://510kreport.com/device/K813521
Methodology: https://510kreport.com/methodology