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510(k) K080908

INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM by Innercool Therapies, Inc.- A Delaware Corporation — Product Code NCX

K080908 is an FDA 510(k) premarket notification submitted by Innercool Therapies, Inc.- A Delaware Corporation for the device "INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM". The FDA issued a decision of Substantially Equivalent on October 17, 2008. The device falls under product code NCX (System, Hypothermia, Intravenous, Cooling), a Class II device regulated under 21 CFR 870.5900.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 2008
Date Received
April 1, 2008
Clearance Type
Special
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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  • 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)
  • K081936 — SOLEX CATHETER, MODEL SL2593 (August 13, 2008)

FDA data resources