# K954651: Electrode Recording Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Oct 22, 1996 after 378 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
No predicates in its family tree.
2 later devices descend from it; 2 cite 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. The FDA summary names its predicate without a number.
- (no number) Polaris catheter: named in the summary without a submission number
- (no number) CardioRhythm Voyagr catheter: named in the summary without a submission number

## Most influential descendants
- K043393: Reprocessed EP Technologies Electrophysiology Catheters (2005), 1 descendant of its own
- K052414: Reprocessed Electrophysiology Catheter (2005), 0 descendants of its own

## Indications for use
The electrode catheter is intended for temporary use in electrophysiologic procedures for intracardiac stimulation and/or recording potentials.

Source page: https://510kreport.com/device/K954651
Methodology: https://510kreport.com/methodology