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510(k) K080899

ARCTIC BLAST INTRAVENOUS FLUID CHILLER by Medivance, Inc. — Product Code NCX

K080899 is an FDA 510(k) premarket notification submitted by Medivance, Inc. for the device "ARCTIC BLAST INTRAVENOUS FLUID CHILLER". The FDA issued a decision of Substantially Equivalent on August 7, 2008. The device falls under product code NCX (System, Hypothermia, Intravenous, Cooling), a Class II device regulated under 21 CFR 870.5900. Medivance, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 7, 2008
Date Received
March 31, 2008
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 Medivance, Inc.

  • K251974 — Arctic Sun Temperature Management System (Model 5000) (October 24, 2025)
  • K243942 — Arctic Sun Stat Temperature Management System (April 30, 2025)
  • K200225 — Arctic Sun Stat Temperature Management System (February 28, 2020)
  • K161602 — Arctic Sun Temperature Management System (September 2, 2016)
  • K142702 — Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, (December 18, 2014)
  • K120849 — HYBRID ARCTICGEL PAD (July 20, 2012)
  • K110956 — MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR (July 18, 2011)
  • K101092 — ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 (July 16, 2010)
  • K071341 — MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 (August 3, 2007)
  • K010338 — ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 (March 7, 2001)

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