K150046 is an FDA 510(k) clearance for the Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter. 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 October 30, 2015, 291 days after receiving the submission on January 12, 2015.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 870.5900.
| 510(k) Number | K150046 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | January 12, 2015 |
| Decision Date | October 30, 2015 |
| Days to Decision | 291 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 |