K153226 is an FDA 510(k) clearance for the Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit. 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 March 24, 2016, 139 days after receiving the submission on November 6, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.5900.
| 510(k) Number | K153226 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | November 06, 2015 |
| Decision Date | March 24, 2016 |
| Days to Decision | 139 days |
| Submission Type | Traditional |
| 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 |