Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogar

System, Hypothermia, Intravenous, Cooling

ZOLL Circulation, Inc

The following data is part of a premarket notification filed by Zoll Circulation, Inc with the FDA for Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, Icy Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard Hq Start-up Kit, Thermogard Hq Start-up Kit Ex, Thermogar.

Pre-market Notification Details

Device IDK220008
510k NumberK220008
Device Name:Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogar
ClassificationSystem, Hypothermia, Intravenous, Cooling
Applicant ZOLL Circulation, Inc 2000 Ringwood Avenue San Jose,  CA  95131
ContactElizabeth Haines
CorrespondentElizabeth Haines
ZOLL Circulation, Inc 2000 Ringwood Avenue San Jose,  CA  95131
Product CodeNCX  
CFR Regulation Number870.5900 [🔎]
DecisionSE - With Limitations (SESU)
TypeTraditional
3rd Party ReviewedNo
Combination ProductYes
Date Received2022-01-04
Decision Date2022-06-02

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