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510(k) K012512

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

K012512 is an FDA 510(k) premarket notification submitted by Radiant Medical for the device "SETPOINT ENDOVASCULAR TEMPERATURE MANAGEMENT SYSTEM". The FDA issued a decision of Substantially Equivalent on June 11, 2002. 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
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)

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