510(k) K150046 ยท NCX System, Hypothermia, Intravenous, Cooling
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter
| Applicant | Zoll Circulation, Inc., San Jose CA, US |
| Decision | Unknown, Oct 30, 2015 |
| Received | Jan 12, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K150046
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll REF: 8700-0782-01 (IC-3893), ICY Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens) , Femoral vein Insertion Only, Sterile EO, Rx Only, UDI: (01)00849 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF: 8700-0791-01 (IC-4593), Premium Access Kit QUATTRO, Intravascular Heat exchange Catheter Kit (Heparin), with central venous infusion capabilities (3 lumens), Femoral Vein Insertion Only, St Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. ZOLL, REF: 8700-0781-01 (CL-2295), COOL LINE, Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin, STERILE EO, Rx only, UDI: (01)00849111075190 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. ZOLL, REF 8700-0781-14 (CL-2295CO), COOL LINE Intravascular Heat Exchange Catheter kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)008491110755 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. ZOLL, REF 8700-0781-40 (CL-2295AE), COOL LINE Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens) HEPARIN COATED, STERILE EO, Rx Only, UDI: (01)0084911107521 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. ZOLL, REF 8700-0787-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), STERILE EO, Rx Only, UDI: (01)00849111075220 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll REF: 8700-0782-40 (IC-3893AE), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens),HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075251 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll REF: 8700-0783-01 (IC-4593), QUATTRO Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin, Sterile EO, Rx Only, UDI: (01)00849111075282 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll REF: 8700-0783-40 (IC-4593AE), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075275 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll REF: 8700-0782-14 (IC-3893CO), ICY Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)00849111075527 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll REF: 8700-0783-14 (IC-4593CO), QUATTRO Intravascular Heat Exchange Catheter Kit with central venous infusion capabilities (3 lumens), HEPARIN COATED, Sterile EO, Rx Only, UDI: (01)0084911107553 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF: 8700-0783-03 (IC-4593AE) QUATTRO Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075305 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-0781-03 (CL-2295AE), COOLINE Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)0084911105 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-0782-03 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111050180 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-0695-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Sterile EO, Rx Only, UDI: (01)00849111075077 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-0657-40 (IC-3893AE), ICY Intravascular Heat Intravascular Heat Exchange Catheter Kit, with central venous infusion capabilities (3 lumens), Heparin, Sterile EO, Rx Only, UDI: (01)00849 Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000766-01, Quattro IVTM Premium Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000870-40, ICY (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer Terminated |
NCX | None listed |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000871-40, Quattro (Heparin) IVTM Disposable Pack and Start UP Kit (6 ft.), EU, New Luer Terminated |
NCX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.