ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER

Electrode, Pacemaker, Temporary

ZCV ,INC.

The following data is part of a premarket notification filed by Zcv ,inc. with the FDA for Zynergy Balloonpace Balloon Guided Pacing And Monitoring Catheter.

Pre-market Notification Details

Device IDK002603
510k NumberK002603
Device Name:ZYNERGY BALLOONPACE BALLOON GUIDED PACING AND MONITORING CATHETER
ClassificationElectrode, Pacemaker, Temporary
Applicant ZCV ,INC. 298 FERNWOOD AVE. Edison,  NJ  08837
ContactJing Zhang
CorrespondentJing Zhang
ZCV ,INC. 298 FERNWOOD AVE. Edison,  NJ  08837
Product CodeLDF  
CFR Regulation Number870.3680 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-08-22
Decision Date2001-01-08

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