# K152633: Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Oct 15, 2015 after 30 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 K813521 (1982). 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)
- K813521: Transluminal Bipolar Pacing Probe, American Edwards Laboratories (1982) Summary page 4.

## Most influential descendants
- 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

## Indications for use
The Chandler Transluminal V-Pacing Probe is indicated for temporary emergency ventricular pacing when used with a Swan-Ganz Paceport or A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraventricular ECG detection (during placement). The Flex-Tip Transluminal A-Pacing Probe is indicated for temporary emergency atrial pacing or sequential A-V pacing when used with a Swan-Ganz A-V Paceport catheter, and can be inserted with or without the aid of fluoroscopy. The probe can also be used for intraatrial ECG detection (during placement).

Source page: https://510kreport.com/device/K152633
Methodology: https://510kreport.com/methodology