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510(k) K030421

ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM by Alsius Corp. — Product Code NCX

K030421 is an FDA 510(k) premarket notification submitted by Alsius Corp. for the device "ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM". The FDA issued a decision of Substantially Equivalent on October 23, 2003. The device falls under product code NCX (System, Hypothermia, Intravenous, Cooling), a Class II device regulated under 21 CFR 870.5900. Alsius Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 2003
Date Received
February 10, 2003
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

Other clearances by Alsius Corp.

  • K081936 — SOLEX CATHETER, MODEL SL2593 (August 13, 2008)
  • K072234 — THERMOGARD XP THERMAL REGULATION SYSTEM (August 23, 2007)
  • K070161 — QUATTRO CATHETER MODEL IC4593 (February 15, 2007)
  • 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)
  • K014241 — COOLGARD 3000, COOLINE, START-UP, MODELS 3000, CL-2085B, CL-2295A, CG-500D (August 1, 2003)

Other clearances for product code NCX

  • K223746 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Excha (January 13, 2023)
  • K220008 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Excha (June 2, 2022)
  • 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)

FDA data resources