# K011766: 6F Evaluator Electrophysiology Catheter, CRD # 402720,402722; 6F Eavuator Electrophysisology Catheter, JSN #402721, 4027

- Pathway: 510(k) (Special)
- Applicant: St Jude Medical
- Decided: Jul 3, 2001 after 26 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.
No later device cites it as a predicate yet.
0 of 1 device 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) Response™ Electrophysiology Catheter: named in the summary without a submission number

## Indications for use
The St. Jude Medical electrophysiology catheters can be used in the evaluation of a variety of cardiac arrhythmias.

Source page: https://510kreport.com/device/K011766
Methodology: https://510kreport.com/methodology