510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010099Substantially Equivalent

Zynergy Z3k Balloon Guided Pacing and Monitoring Catheter

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

K010099 is the FDA 510(k) clearance record for ZYNERGY Z3K BALLOON GUIDED PACING AND MONITORING CATHETER, a class II device, cleared for Zcv ,Inc. on under FDA product code LDF (Electrode, Pacemaker, Temporary). FDA records list 6 510(k) clearances for Zcv ,Inc., from to . As of , FDA records show no recalls naming K010099.

Clearance record

Decision date
Received
(21 days to decision)
Product code
LDF Electrode, Pacemaker, Temporary
Regulation
21 CFR 870.3680
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 LDF

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