COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593

System, Hypothermia, Intravenous, Cooling

ZOLL CIRCULATION

The following data is part of a premarket notification filed by Zoll Circulation with the FDA for Cool Line Catheter, Model Cl-2295a, Icy Catheter, Model Ic-3893a And Quattro Catheter, Model Ic-4593.

Pre-market Notification Details

Device IDK101987
510k NumberK101987
Device Name:COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593
ClassificationSystem, Hypothermia, Intravenous, Cooling
Applicant ZOLL CIRCULATION 650 ALMANOR AVENUE Sunnyvale,  CA  94085
ContactSam Nanavati
CorrespondentSam Nanavati
ZOLL CIRCULATION 650 ALMANOR AVENUE Sunnyvale,  CA  94085
Product CodeNCX  
CFR Regulation Number870.5900 [🔎]
DecisionSe - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-07-14
Decision Date2010-10-12
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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