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510(k) K141139

SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER by Zoll Circulation — Product Code NCX

K141139 is an FDA 510(k) premarket notification submitted by Zoll Circulation for the device "SOLEX INTRAVASCULAR HEAT EXCHANGE CATHETER". The FDA issued a decision of Substantially Equivalent on October 3, 2014. The device falls under product code NCX (System, Hypothermia, Intravenous, Cooling), a Class II device regulated under 21 CFR 870.5900. Zoll Circulation has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 2014
Date Received
May 2, 2014
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 Zoll Circulation

  • K250979 — Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Managem (October 15, 2025)
  • K231182 — Thermogard HQ™ Temperature Management System, Thermogard XP® Temperature Managem (November 3, 2023)
  • K221700 — AutoPulse NXT Resuscitation System (March 9, 2023)
  • 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)
  • 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)
  • K112998 — AUTOPULSE RESUSCITATION SYSTEM MODEL 1000 (March 15, 2012)
  • K101987 — COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CAT (October 12, 2010)

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)
  • 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)
  • K081936 — SOLEX CATHETER, MODEL SL2593 (August 13, 2008)

FDA data resources