510(k) K220008 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 HQ Start-Up Kit, Thermogard HQ Start-Up Kit EX, Thermogard HQ Console
| Applicant | Zoll Circulation, Inc., San Jose CA, US |
| Decision | Unknown, Jun 2, 2022 |
| Received | Jan 4, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220008
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.