FDA.reportPublic FDA data

510(k) K213031

Device
Solex 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 Console
Applicant
Zoll Circulation, Inc.
510(k) number
K213031
Product code
NCX
Decision
Unknown (SESU)
Decision date
2021-12-20
Date received
2021-09-21
Regulation
870.5900
Classification name
System, Hypothermia, Intravenous, Cooling
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Elizabeth Haines
Address
200 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
K223746Solex 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 ConsoleZoll Circulation, Inc.2023-01-13
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
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