510(k) K213031 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, Start-Up Kit, Coolgard 3000 Console, Thermogard XP Console
| Applicant | Zoll Circulation, Inc., San Jose CA, US |
| Decision | Unknown, Dec 20, 2021 |
| Received | Sep 21, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K213031
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.