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— 510(k) K223746

Clearance details

Applicant

Zoll Circulation, Inc.

Product code

Code NCX

Device class

Class 2

Regulation

21 CFR 870.5900

Advisory panel

Cardiovascular

Date received

2022-12-14

Decision date

2023-01-13

Decision

Unknown

Clearance type

Special

Location

San Jose, CA, US

• 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 Console2022-06-02
• 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 Console2021-12-20
• K152946 — TEMPEDY2016-09-15
• K153162 — Hypocore2016-05-24
• K153226 — Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit2016-03-24

• K250979 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System (VitalTemp Universal Pad)2025-10-15
• K231182 — Thermogard HQ Temperature Management System, Thermogard XP® Temperature Management System2023-11-03
• K221700 — AutoPulse NXT Resuscitation System2023-03-09
• K150046 — Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter2015-10-30

Death

30

Malfunction

2,302

Total

2,332

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →