# K971504: Hexapolar Electrode Balloon Flotation Catheter

- Pathway: 510(k) (Traditional)
- Applicant: J-Lloyd Medical, Inc.
- Decided: Apr 20, 1998 after 360 days
- Product code: DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording)
- Device class: 2
- Regulation: 21 CFR 870.1220
- 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 K930069 (1994). 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)
- K930069: Bipolar Balloon Pacing Catheter by J-Lloyd, J-Lloyd Medical, Inc. (1994) Summary page 1.

## Indications for use
The Hexapolar Electrode Balloon Floatation Catheter is designed to provide diagnostic information. It is intended to be used for the following: 1. Temporary use in electrophysiology studies; 2. Intra-cardiac ECG; and 3. Electrical stimulation.

Source page: https://510kreport.com/device/K971504
Methodology: https://510kreport.com/methodology