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510(k) K024327

SETPOINT ENDOVASCULAR TEMPERATURE PROBE by Radiant Medical — Product Code DQY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2003
Date Received
December 26, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Percutaneous
Device Class
Class II
Regulation Number
870.1250
Review Panel
CV
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)
  • K012512 — SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM (June 11, 2002)

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