510(k) K223746 ยท NCX System, Hypothermia, Intravenous, Cooling
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
| Applicant | Zoll Circulation, Inc., San Jose CA, US |
| Decision | Unknown, Jan 13, 2023 |
| Received | Dec 14, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K223746
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.