System, Hypothermia, Intravenous, Cooling

FDA product code NCX · 24 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.5900
Review panel: NE
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 2002-06-11 – 2023-01-13

NCX 2023-01-13

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.

K number K223746

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NCX 2022-06-02

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, Thermogard HQ Console

Applicant Zoll Circulation, Inc.

K number K220008

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NCX 2021-12-20

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.

K number K213031

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NCX 2016-09-15

TEMPEDY

Applicant Seiratherm GmbH

K number K152946

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NCX 2016-05-24

Hypocore

Applicant Novocor Medical Systems, Inc.

K number K153162

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NCX 2016-03-24

Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit

Applicant Zoll Circulation, Inc.

K number K153226

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NCX 2010-10-12

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

Applicant Zoll Circulation

K number K101987

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NCX 2008-10-17

INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM

Applicant Innercool Therapies, Inc.- A Delaware Corporation

K number K080908

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NCX 2008-08-13

SOLEX CATHETER, MODEL SL2593

Applicant Alsius Corp.

K number K081936

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NCX 2008-08-07

ARCTIC BLAST INTRAVENOUS FLUID CHILLER

Applicant Medivance, Inc.

K number K080899

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NCX 2007-08-23

THERMOGARD XP THERMAL REGULATION SYSTEM

Applicant Alsius Corp.

K number K072234

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NCX 2007-06-01

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

Applicant Radiant Medical

K number K071358

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NCX 2007-05-09

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

Applicant Radiant Medical

K number K071008

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NCX 2007-02-15

QUATTRO CATHETER MODEL IC4593

Applicant Alsius Corp.

K number K070161

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NCX 2007-01-22

THERMOGARD THERMAL REGULATION SYSTEM

Applicant Alsius Corp.

K number K063829

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NCX 2007-01-08

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM

Applicant Radiant Medical

K number K063405

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NCX 2006-04-26

COOLGARD 3000

Applicant Alsius Corp.

K number K060308

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NCX 2005-10-17

ICY CATHETER, MODEL IC-3893A

Applicant Alsius Corp.

K number K052443

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NCX 2005-10-11

COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B

Applicant Alsius Corp.

K number K051912

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NCX 2004-05-21

CELSIUS CONTROL SYSTEM

Applicant Innercool Therapies, Inc.

K number K033623

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NCX 2003-10-23

ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM

Applicant Alsius Corp.

K number K030421

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NCX 2003-08-01

COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D

Applicant Alsius Corp.

K number K014241

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NCX 2003-01-27

CELSIUS CONTROL SYSTEM

Applicant Innercool Therapies

K number K022366

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NCX 2002-06-11

SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM

Applicant Radiant Medical

K number K012512

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