# K991060: Zynergy Zolution Electrophysiology Catheter, Model Z50000

- Pathway: 510(k) (Traditional)
- Applicant: Zcv,Inc.
- Decided: Apr 6, 2000 after 373 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: 1 generation back to K933450 (1995). 2 ancestors in all.
1 later device descends 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)
- K933450: Closed Tip Multi-Electrode Catheter, Modification, Electro-Catheter Corp. (1995) Summary page 1.
- K953651: Diagnostic Electrophysiology Catheter System, Arrow Intl., Inc. (1995) Summary page 1.

## Most influential descendants
- K011847: Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable (2001), 0 descendants of its own

## Indications for use
Zynergy Zolution Electrophysiology Catheter with Zyp-Lok Extension Set is intended for temporary use in electrophysiology studies for intracardiac stimulation and/or ECG recording.

Source page: https://510kreport.com/device/K991060
Methodology: https://510kreport.com/methodology