Medical Device Manufacturer · US , San Jose , CA

Zoll Circulation, Inc.

8 submissions · 3 cleared · Since 2015
8
Total
3
Cleared
0
Denied

Zoll Circulation, Inc. — FDA 510(k) Submissions

Zoll Circulation, Inc. has submitted 8 FDA 510(k) premarket notifications since 2015, of which 3 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Hypothermia, Intravenous, Cooling, Hyperthermia Monitor, Compressor, Cardiac, External . Use the specialty filter in the sidebar to narrow results.

8 devices
1–8 of 8
Thermogard HQ? Temperature Management System, Thermogard XP? Temperature Management System (VitalTemp? Universal Pad)
K250979 · NZE Hyperthermia Monitor · Cardiovascular
Oct 2025 198d
Thermogard HQ? Temperature Management System, Thermogard XP? Temperature Management System
K231182 · NZE Hyperthermia Monitor · Cardiovascular
Nov 2023 191d
AutoPulse NXT Resuscitation System
K221700 · DRM Compressor, Cardiac,... · Cardiovascular
Mar 2023 269d
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
K223746 · NCX System, Hypothermia,... · Neurology
Jan 2023 30d
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
K220008 · NCX System, Hypothermia,... · Neurology
Jun 2022 149d
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
K213031 · NCX System, Hypothermia,... · Neurology
Dec 2021 90d
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
K153226 · NCX System, Hypothermia,... · Neurology
Mar 2016 139d
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
K150046 · NCX System, Hypothermia,... · Neurology
Oct 2015 291d
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