Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter— 510(k) K150046

Clearance details

Applicant

Zoll Circulation, Inc.

Product code

Code NCX

Device class

Class 2

Regulation

21 CFR 870.5900

Advisory panel

Cardiovascular

Date received

2015-01-12

Decision date

2015-10-30

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
• K153226 — Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit2016-03-24

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-0039-2022 — Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849111075237Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0040-2022 — Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, Sterile EO, Rx only, UDI: (01)008491110 7550 3Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0041-2022 — ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0044-2022 — ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075510Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0045-2022 — ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)00849111075213Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0046-2022 — ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0047-2022 — Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0048-2022 — Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0049-2022 — Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0050-2022 — Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0051-2022 — Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075534Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0053-2022 — Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0054-2022 — Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050173Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0055-2022 — Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0056-2022 — Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0057-2022 — Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849111075107Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0058-2022 — Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0060-2022 — Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0061-2022 — Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)Class II·Terminated·ZOLL Circulation, Inc.·20210806
• Z-0064-2022 — Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New LuerClass 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 K150046.