Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit— 510(k) K153226

Clearance details

Applicant

Zoll Circulation, Inc.

Product code

Code NCX

Device class

Class 2

Regulation

21 CFR 870.5900

Advisory panel

Cardiovascular

Date received

2015-11-06

Decision date

2016-03-24

Decision

Unknown

Clearance type

Traditional

Location

San Jose, CA, US

• 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 Console2023-01-13
• 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

• 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 →

• Z-0042-2022 — ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Only, 20 cm, Sterile EO, Rx Only, UDI:Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0043-2022 — ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0052-2022 — Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0062-2022 — Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)Class II·Terminated·ZOLL Circulation, Inc.·20210806

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K153226.