# K011847: Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable

- Pathway: 510(k) (Special)
- Applicant: Zynergy Cardio Vasular (Zcv), Inc.
- Decided: Jul 13, 2001 after 30 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
Longest line of descent: 2 generations back to K933450 (1995). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K991060: Zynergy Zolution Electrophysiology Catheter, Model Z50000, Zcv,Inc. (2000) Summary page 1.

## Indications for use
Identical to the indications of the predicate Zynergy Zolution catheters and cables cleared through 510(k) K991060, Zynergy Z5000 Electrophysiology Catheter With Z9000 Accessory Cable is indicated for temporary use in electrophysiology studies for intracardiac simulation and/or ECG recording.

Source page: https://510kreport.com/device/K011847
Methodology: https://510kreport.com/methodology