510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K991060Substantially Equivalent

Zynergy Zolution Electrophysiology Catheter, Model Z50000

Zcv,Inc., Edison NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K991060 is the FDA 510(k) clearance record for ZYNERGY ZOLUTION ELECTROPHYSIOLOGY CATHETER, MODEL Z50000, a class II device, cleared for Zcv ,Inc. on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 6 510(k) clearances for Zcv ,Inc., from to . As of , FDA records show no recalls naming K991060.

Clearance record

Decision date
Received
(373 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
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