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510(k) K012512

SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM by Radiant Medical — Product Code NCX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 2002
Date Received
August 6, 2001
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)
  • K071008 — REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM (May 9, 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)

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  • K101987 — COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CAT (October 12, 2010)
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