510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K011847Substantially Equivalent

Zynergy Z5000 Electrophysiology Catheter with Z9000 Accessory Cable

Zynergy Cardio Vasular (Zcv), Inc., Edison NJ / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K011847 is the FDA 510(k) clearance record for ZYNERGY Z5000 ELECTROPHYSIOLOGY CATHETER WITH Z9000 ACCESSORY CABLE, a class II device, cleared for Zynergy Cardio Vasular (Zcv), Inc. on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list one 510(k) clearance for Zynergy Cardio Vasular (Zcv), Inc. As of , FDA records show no recalls naming K011847.

Clearance record

Decision date
Received
(30 days to decision)
Product code
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Zynergy Cardio Vasular (Zcv), Inc. 298 Fernwood Ave., Edison NJ
510(k) summary
Summary
Third party review
No

Clearances, product code DRF

Trailing 12 months
1 clearance under product code DRF in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260