# K953750: Catheter, Electrode Recording, or Probe, Electrode Recording

- Pathway: 510(k) (Traditional)
- Applicant: Boston Scientific Corp
- Decided: Mar 11, 1996 after 214 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.
3 later devices descend from it; 1 cites it directly.
0 of 4 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) Elecath Investigator: named in the summary without a submission number
- (no number) Daig Response electrophysiology catheters: named in the summary without a submission number

## Most influential descendants
- K962765: Cordis Marker Wire Steerable Guidewire (Stabilizer with Radiopaque Markers) and (Wizdom with Radiopaque Markers) (1997), 2 descendants of its own
- K993248: Amplatzer Sizing Balloon (2000), 1 descendant of its own
- K053440: Amplatzer Sizing Balloon II (2005), 0 descendants of its own

## Indications for use
The electrode catheter is intended for intracardiac electrogram recording and pacing for the purpose of determining conduction times from one cardiac location to another, to focalize aberrant conduction pathways and to test for the susceptability of the cardiac chambers to arrhythmias.

Source page: https://510kreport.com/device/K953750
Methodology: https://510kreport.com/methodology