510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K003118Substantially Equivalent

Z2 Balloon Guided Pacing & Pressure Monitoring Catheter, Model Z2-7-02-1-10-0

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

K003118 is the FDA 510(k) clearance record for Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0, a class II device, cleared for Zcv ,Inc. on under FDA product code DYG (Catheter, Flow Directed). FDA records list 6 510(k) clearances for Zcv ,Inc., from to . As of , FDA records show no recalls naming K003118.

Clearance record

Decision date
Received
(76 days to decision)
Product code
DYG Catheter, Flow Directed
Regulation
21 CFR 870.1240
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 DYG

Trailing 12 months

FDA records hold no clearances under product code DYG in the trailing twelve months.

FDA records show no clearances under product code DYG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DYG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260