Anesthesiology
Review Panel
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- MiscellaneousMiscellaneous
- Subpart B—Cardiovascular Diagnostic DevicesCFR Sub-Part
- Subpart B—Diagnostic DevicesCFR Sub-Part
- Subpart B—Neurological Diagnostic DevicesCFR Sub-Part
- Subpart B—Physical Medicine Diagnostic DevicesCFR Sub-Part
- Subpart C—Cardiovascular Monitoring DevicesCFR Sub-Part
- Subpart D—Physical Medicine Prosthetic DevicesCFR Sub-Part
- Subpart E—Neurological Surgical DevicesCFR Sub-Part
- Subpart E—Surgical DevicesCFR Sub-Part
- Subpart F—Cardiovascular Therapeutic DevicesCFR Sub-Part
- NCXSystem, Hypothermia, Intravenous, Cooling2Product Code
- 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 Console2Cleared 510(K)
- 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 Console2Cleared 510(K)
- 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 Console2Cleared 510(K)
- K152946TEMPEDY2Cleared 510(K)
- K153162Hypocore2Cleared 510(K)
- K153226Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit2Cleared 510(K)
- K150046Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter2Cleared 510(K)
- K141139SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER2Cleared 510(K)
- K101987COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-45932Cleared 510(K)
- K080908INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM2Cleared 510(K)
- K081936SOLEX CATHETER, MODEL SL25932Cleared 510(K)
- K080899ARCTIC BLAST INTRAVENOUS FLUID CHILLER2Cleared 510(K)
- K072234THERMOGARD XP THERMAL REGULATION SYSTEM2Cleared 510(K)
- K071358REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM2Cleared 510(K)
- K071008REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM2Cleared 510(K)
- K070161QUATTRO CATHETER MODEL IC45932Cleared 510(K)
- K063829THERMOGARD THERMAL REGULATION SYSTEM2Cleared 510(K)
- K063405REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM2Cleared 510(K)
- K060308COOLGARD 30002Cleared 510(K)
- K052443ICY CATHETER, MODEL IC-3893A2Cleared 510(K)
- K051912COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-3585A; FORTIUS CATHETER KIT, MOD. FR-5093B2Cleared 510(K)
- K033623CELSIUS CONTROL SYSTEM2Cleared 510(K)
- K030421ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM2Cleared 510(K)
- K014241COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D2Cleared 510(K)
- K022366CELSIUS CONTROL SYSTEM2Cleared 510(K)
- K012512SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM2Cleared 510(K)
- Subpart F—Neurological Therapeutic DevicesCFR Sub-Part
- Subpart F—Physical Medicine Therapeutic DevicesCFR Sub-Part
- Subpart F—Therapeutic DevicesCFR Sub-Part
- Obstetrical and GynecologicalReview Panel
- OphthalmicReview Panel
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COOLGARD 3000
- Page Type
- Cleared 510(K)
- PDF* The FDA doesn't provide PDFs for all submissions.
- Analyzed PDF
- 510(k) Number
- K060308
- 510(k) Type
- Traditional
- Applicant
- Alsius Corp.
- Country
- United States
- FDA Decision
- Substantially Equivalent - With Limitations
- Decision Date
- 4/26/2006
- Days to Decision
- 78 days
- Submission Type
- Summary