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510(k) K071008

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

Clearance Details

Decision
SESU ()
Decision Date
May 9, 2007
Date Received
April 9, 2007
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 Radiant Medical

  • K071358 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (June 1, 2007)
  • K063405 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (January 8, 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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