510(k) K153226 ยท NCX System, Hypothermia, Intravenous, Cooling
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit
| Applicant | Zoll Circulation, Inc., San Jose CA, US |
| Decision | Unknown, Mar 24, 2016 |
| Received | Nov 6, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153226
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2021 | ZOLL Circulation, Inc. ZOLL, REF 8700-0793-01 (SL-2593) Premium Access Kit SOLEX 7, Intravascular Heat Exchange catheter Kit, with central venous infusion capabilities (3 lumens), Use Jugular or Subclavian Vein Approach Onl Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. ZOLL, REF 8700-0793-40 (SL-2593AE) SOLEX 7, Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (00)849111075312 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll REF: 8700-0793-14 (SL-2593CO), SOLEX 7 Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), Heparin COATED, Sterile EO, Rx Only, UDI: (01)00849111075541 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.