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510(k) K014241

COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D by Alsius Corp. — Product Code NCX

Clearance Details

Decision
SESU ()
Decision Date
August 1, 2003
Date Received
December 26, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Hypothermia, Intravenous, Cooling
Device Class
Class II
Regulation Number
870.5900
Review Panel
NE
Submission Type

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  • K063829 — THERMOGARD THERMAL REGULATION SYSTEM (January 22, 2007)
  • K060308 — COOLGARD 3000 (April 26, 2006)
  • K052443 — ICY CATHETER, MODEL IC-3893A (October 17, 2005)
  • K051912 — COOL LINE CATHETER KIT, MODELS CL-2085B, CL-2295A; ICY CATHETER KIT, MODEL IC-35 (October 11, 2005)
  • K030421 — ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM (October 23, 2003)

Other clearances for product code NCX

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  • K213031 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Excha (December 20, 2021)
  • K152946 — TEMPEDY (September 15, 2016)
  • K153162 — Hypocore (May 24, 2016)
  • K153226 — Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit (March 24, 2016)
  • K150046 — Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravas (October 30, 2015)
  • K141139 — SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER (October 3, 2014)
  • K101987 — COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CAT (October 12, 2010)
  • K080908 — INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM (October 17, 2008)