FDA Product Code NCX: System, Hypothermia, Intravenous, Cooling
Leading manufacturers include Zoll Circulation, Inc..
26
Total
26
Cleared
145d
Avg days
2002
Since
Declining activity -
0 submissions in the last 2 years
vs 2 in the prior period
FDA 510(k) Cleared System, Hypothermia, Intravenous, Cooling Devices (Product Code NCX)
26 devices
Cleared
Jan 13, 2023
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard XP Console, Thermogard HQ Console
Zoll Circulation, Inc.
Neurology
30d
Cleared
Jun 02, 2022
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Thermogard HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
Zoll Circulation, Inc.
Neurology
149d
Cleared
Dec 20, 2021
Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
Zoll Circulation, Inc.
Neurology
90d
About Product Code NCX - Regulatory Context
510(k) Submission Activity
26 total 510(k) submissions under product code NCX since 2002, with 26 receiving FDA clearance (average review time: 145 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 2 in the prior period.
NCX devices are reviewed by the Neurology panel. Browse all Neurology devices →