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510(k) K063405

REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM by Radiant Medical — Product Code NCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2007
Date Received
November 9, 2006
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

Other clearances by Radiant Medical

  • K071358 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (June 1, 2007)
  • K071008 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (May 9, 2007)
  • K042388 — RADIANT MEDICAL ENDOCATHETER TEMPERATURE PROBE (October 28, 2004)
  • K024327 — SETPOINT ENDOVASCULAR TEMPERATURE PROBE (March 25, 2003)
  • K012512 — SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM (June 11, 2002)

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  • K152946 — TEMPEDY (September 15, 2016)
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  • 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)