# K933450: Closed Tip Multi-Electrode Catheter, Modification

- Pathway: 510(k) (Traditional)
- Applicant: Electro-Catheter Corp.
- Decided: Apr 19, 1995 after 646 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; 1 cites 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. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K991060: Zynergy Zolution Electrophysiology Catheter, Model Z50000 (2000), 1 descendant of its own
- K011847: Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable (2001), 0 descendants of its own

Source page: https://510kreport.com/device/K933450
Methodology: https://510kreport.com/methodology
