FDA.reportPublic FDA data

510(k) K223746

Device
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
Applicant
Zoll Circulation, Inc.
510(k) number
K223746
Product code
NCX
Decision
Unknown (SESU)
Decision date
2023-01-13
Date received
2022-12-14
Regulation
870.5900
Classification name
System, Hypothermia, Intravenous, Cooling
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brian Robey
Address
2000 Ringwood Ave. San Jose CA US 95131 95131

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NCX#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220008Solex 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, Thermogard HQ ConsoleZoll Circulation, Inc.2022-06-02
K213031Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP ConsoleZoll Circulation, Inc.2021-12-20
K152946TEMPEDYSeiratherm GmbH2016-09-15
K153162HypocoreNovocor Medical Systems, Inc.2016-05-24
K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitZoll Circulation, Inc.2016-03-24
K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange CatheterZoll Circulation, Inc.2015-10-30
K141139SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETERZoll Circulation2014-10-03
K101987COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593Zoll Circulation2010-10-12
K080908INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEMInnercool Therapies, Inc.- A Delaware Corporation2008-10-17
K081936SOLEX CATHETER, MODEL SL2593Alsius Corp.2008-08-13
K080899ARCTIC BLAST INTRAVENOUS FLUID CHILLERMedivance, Inc.2008-08-07
K072234THERMOGARD XP THERMAL REGULATION SYSTEMAlsius Corp.2007-08-23
K071358REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMRadiant Medical2007-06-01
K071008REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEMRadiant Medical2007-05-09
K070161QUATTRO CATHETER MODEL IC4593Alsius Corp.2007-02-15