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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Flow Directed
510(k) Number K003118
Device Name Z2 BALLOON GUIDED PACING & PRESSURE MONITORING CATHETER, MODEL Z2-7-02-1-10-0
Applicant
Zcv ,Inc.
298 Fernwood Ave.
Edison,  NJ  08837
Applicant Contact JING ZHANG
Correspondent
Zcv ,Inc.
298 Fernwood Ave.
Edison,  NJ  08837
Correspondent Contact JING ZHANG
Regulation Number870.1240
Classification Product Code
DYG  
Date Received10/05/2000
Decision Date 12/20/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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