Zoll Circulation, Inc.
FDA 510(k) & PMA Approved Devices — 8 products
Total Devices8
Categories4
Latest Approval2025-10-15
| Type | Number | Device Name | Code | Date | |
|---|---|---|---|---|---|
| 510(k) | K250979 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad) | NZE | 2025-10-15 | View |
| 510(k) | K231182 | Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System | NZE | 2023-11-03 | View |
| 510(k) | K221700 | AutoPulse NXT Resuscitation System | DRM | 2023-03-09 | View |
| 510(k) | K223746 | 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 | NCX | 2023-01-13 | View |
| 510(k) | K220008 | 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 | NCX | 2022-06-02 | View |
| 510(k) | K213031 | 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 | NCX | 2021-12-20 | View |
| PMA | P170027 | System, oxygen, aqueous | MWG | 2019-04-02 | View |
| 510(k) | K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit | NCX | 2016-03-24 | View |
No matching devices.