# K033963: EP Deflectable Catheters

- Pathway: 510(k) (Special)
- Applicant: Ep Medsystems, Inc.
- Decided: Apr 15, 2004 after 115 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. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K041638: Targetscan Biopsy Kit (2004), 2 descendants of its own
- K073399: Targetscan Biopsy Kit, Targetscan Biopsy Needle Guide (2007), 1 descendant of its own
- K081323: Biopsy Guide Kit for 8808 and Biplane, Endfire and Dual Biopsy Guides for 8818 (2008), 0 descendants of its own

## Indications for use
The EP Deflectable Catheters are designed for one time single patient use for temporary use in electrophysiology studies. Models can be use in conjunction with EPMedSystems' EP Workmate.

Source page: https://510kreport.com/device/K033963
Methodology: https://510kreport.com/methodology