K223746 is an FDA 510(k) clearance for the 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. This device is classified as a System, Hypothermia, Intravenous, Cooling (Class II - Special Controls, product code NCX).
Submitted by Zoll Circulation, Inc. (San Jose, US). The FDA issued a Cleared decision on January 13, 2023, 30 days after receiving the submission on December 14, 2022.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.5900.
| 510(k) Number | K223746 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | December 14, 2022 |
| Decision Date | January 13, 2023 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | NCX - System, Hypothermia, Intravenous, Cooling |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5900 |