System, Hypothermia, Intravenous, Cooling
FDA product code NCX · Class II (moderate risk) · 21 CFR 870.5900 · Cardiovascular
26510(k) clearances
0PMA approvals
31recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K223746 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Special | Zoll Circulation, Inc. | 01/13/2023SESU |
| K220008 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | Zoll Circulation, Inc. | 06/02/2022SESU |
| K213031 | Solex 7 Intravascular Heat Exchange Catheter, Cool Line Intravascular Heat Exchange…NCX · Traditional | Zoll Circulation, Inc. | 12/20/2021SESU |
| K152946 | TempedyNCX · Traditional | Seiratherm GmbH | 09/15/2016SE |
| K153162 | HypocoreNCX · Traditional | Novocor Medical Systems, Inc. | 05/24/2016SE |
| K153226 | Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up KitNCX · Traditional | Zoll Circulation, Inc. | 03/24/2016SESU |
| K150046 | Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular…NCX · Traditional | Zoll Circulation, Inc. | 10/30/2015SESU |
| K141139 | Solex Intravascular Heat Exchange CatheterNCX · Traditional | Zoll Circulation | 10/03/2014SE |
| K101987 | Cool Line Catheter, Model CL-2295A, Icy Catheter, Model IC-3893A and Quattro Catheter…NCX · Traditional | Zoll Circulation | 10/12/2010SESU |
| K080908 | Innercool Therapies, Inc., Rapidblue SystemNCX · Special | Innercool Therapies, Inc.- A Delaware Corporation | 10/17/2008SE |
| K081936 | Solex Catheter, Model SL2593NCX · Traditional | Alsius Corp. | 08/13/2008SE |
| K080899 | Arctic Blast Intravenous Fluid ChillerNCX · Traditional | Medivance, Inc. | 08/07/2008SE |
| K072234 | Thermogard XP Thermal Regulation SystemNCX · Special | Alsius Corp. | 08/23/2007SE |
| K071358 | Reprieve Endovascular Temperature Therapy SystemNCX · Traditional | Radiant Medical | 06/01/2007SE |
| K071008 | Reprieve Endovascular Temperature Therapy SystemNCX · Traditional | Radiant Medical | 05/09/2007SESU |
| K070161 | Quattro Catheter Model IC4593NCX · Traditional | Alsius Corp. | 02/15/2007SE |
| K063829 | Thermogard Thermal Regulation SystemNCX · Special | Alsius Corp. | 01/22/2007SESU |
| K063405 | Reprieve Endovascular Temperature Therapy SystemNCX · Special | Radiant Medical | 01/08/2007SE |
| K060308 | Coolgard 3000NCX · Traditional | Alsius Corp. | 04/26/2006SESU |
| K052443 | Icy Catheter, Model IC-3893ANCX · Traditional | Alsius Corp. | 10/17/2005SE |
| K051912 | Cool Line Catheter Kit, Models CL-2085B, CL-2295A; Icy Catheter Kit, Model IC-3585A…NCX · Traditional | Alsius Corp. | 10/11/2005SESU |
| K033623 | Celsius Control SystemNCX · Traditional | Innercool Therapies, Inc. | 05/21/2004SE |
| K030421 | Alsius Coolgard 3000 & Alsius Catheter SystemNCX · Traditional | Alsius Corp. | 10/23/2003SE |
| K014241 | Coolgard 3000, Cooline, Start-Up, Models 3000, CL-2085B, CL-2295A, CG-500DNCX · Traditional | Alsius Corp. | 08/01/2003SESU |
| K022366 | Celsius Control SystemNCX · Traditional | Innercool Therapies | 01/27/2003SE |
| K012512 | Setpoint Endovascular Temperature Management SystemNCX · Traditional | Radiant Medical | 06/11/2002SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-0066-2022 Class II | Zoll, REF 8700-000872-40, SOLEX 7(Heparin) IVTM Disposable Pack and Start UP Kit (6…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0065-2022 Class II | Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0064-2022 Class II | Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.)…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0063-2022 Class II | Zoll, REF 8700-000869-40, Cool Line (Heparin) IVTM Disposable Pack and Start UP Kit (6…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0062-2022 Class II | Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.)Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0061-2022 Class II | Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.)Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0060-2022 Class II | Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.)Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0059-2022 Class II | Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.)Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0058-2022 Class II | Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.)Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0057-2022 Class II | Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0056-2022 Class II | Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0055-2022 Class II | Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0054-2022 Class II | Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0053-2022 Class II | Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0052-2022 Class II | Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0051-2022 Class II | Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0050-2022 Class II | Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0049-2022 Class II | Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0048-2022 Class II | Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0047-2022 Class II | Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0046-2022 Class II | ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0045-2022 Class II | ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0044-2022 Class II | ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0043-2022 Class II | ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0042-2022 Class II | ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0041-2022 Class II | ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0040-2022 Class II | Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0039-2022 Class II | Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with…Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing | ZOLL Circulation, Inc. | 08/06/2021Terminated |
| Z-0845-2014 Class II | InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V). Product…Phillips Healthcare initiated this action because the Main Control Board (MCB) may produce an inaccurate low… | Philips Healthcare | 01/13/2014Terminated |
| Z-0503-2007 | Alsius Cool Line Catheter, Model CL-2295AETesting by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a… | Alsius Corporation | 01/01/2007Terminated |
| Z-0502-2007 | Alsius Cool Line Catheter, Model CL-2295ATesting by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a… | Alsius Corporation | 01/01/2007Terminated |