Panels › Cardiovascular › Product code NCX · Class 2
System, Hypothermia, Intravenous, Cooling
Regulation 870.5900
0510(k)s in 12 months (26 all time)
0recalls in 12 months (35 all time)
32recalls that name a 510(k)
Top companies in NCX
| Company | 510(k)s | Recalls |
|---|---|---|
| Zoll Circulation | 7 | 28 |
| Alsius Corp. | 9 | 6 |
| Radiant Medical | 4 | 0 |
| Innercool Therapies | 2 | 0 |
| Innercool Therapies, Inc.- A Delaware Corporation | 1 | 0 |
| Medivance, Inc. | 1 | 0 |
| Novocor Medical Systems, Inc. | 1 | 0 |
| Philips Healthcare | 0 | 1 |
| Seiratherm GmbH | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000872-40, SOLEX 7(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 | K150046 |
| 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 | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000869-40, Cool Line (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 8700-000868-01, Solex 7 IVTM Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | K153226 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000867-01, Quattro IVTM Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000866-01, ICY IVTM Disposable Pack and Start UP Kit (6 ft.) Terminated |
NCX | K150046 |
| Aug 6, 2021 | ZOLL Circulation, Inc. Zoll, REF 8700-000865-01, Cool Line IVTM Disposable Pack and Start UP Kit (6 ft.) 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 | K150046 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K153226 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K153226 |
| 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 | K153226 |
| 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 | K150046 |
| 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 | K150046 |
| 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 | K150046 |
| Jan 27, 2014 | Philips Healthcare InnerCool RTx Endovascular System, Model Numbers: 861470 (120V), 861472 (240V).
Product Usage:
The InnerCool RTx device is a thermal regulating system intended to induce, maintain and reverse mild hy Terminated |
NCX | K080908 |
| Feb 15, 2007 | Alsius Corporation Alsius Cool Line Catheter, Model CL-2295AE Terminated |
NCX | K014241 |
| Feb 15, 2007 | Alsius Corporation Alsius Cool Line Catheter, Model CL-2295A Terminated |
NCX | K014241 |
| Jan 10, 2006 | Alsius Corporation Alsius CoolGard Temperature Regulation System Terminated |
NCX | K014241 K030421 |
| Aug 24, 2005 | Alsius Corporation Alsius CoolGard 3000 Temperature Regulation System Terminated |
NCX | K014241 K030421 |
| Nov 25, 2004 | Alsius Corporation Alsius CoolGard 3000 patient temperature regulation system Terminated |
NCX | K014241 K030421 |
| Jul 23, 2004 | Alsius Corporation Alsius CoolGuard 3000 Temperature Regulation System, Model CoolGuard 3000 Terminated |
NCX | K014241 K030421 |
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