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510(k) K063405

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

K063405 is an FDA 510(k) premarket notification submitted by Radiant Medical for the device "REPRIEVE ENDOVASCULAR TEMPERATURE THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 8, 2007. The device falls under product code NCX (System, Hypothermia, Intravenous, Cooling), a Class II device regulated under 21 CFR 870.5900. Radiant Medical has at least 5 other 510(k) clearances on record.

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)

Other clearances for product code NCX

  • K223746 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Excha (January 13, 2023)
  • K220008 — Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Excha (June 2, 2022)
  • 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)
  • K080908 — INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM (October 17, 2008)

FDA data resources