Home › Device types › NCX
System, Hypothermia, Intravenous, Cooling
FDA product code NCX · Class 2 · Cardiovascular
61
Registered devices
4,389
Adverse events
35
Recalls
26
510(k) clearances
Devices with this code
Thermogard XP® — Zoll Circulation, Inc.14F PACKAGED ACCUTROL CATHETER — Zoll Circulation, Inc.Start-Up Kit Japan — Zoll Circulation, Inc.Start-Up Kit Extended Length, Custom Luer — Zoll Circulation, Inc.Start-Up Kit Custom Luer — Zoll Circulation, Inc.SOLEX® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin EU — Zoll Circulation, Inc.Cool Line® Intravascular Heat Exchange Catheter Kit US (Surmodics Non-Lidocaine) — Zoll Circulation, Inc.Thermogard XP, Lang set B, Rohs, Refurb — Zoll Circulation, Inc.ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin), Non Lidocaine — Zoll Circulation, Inc.Thermogard XP, Lang set A, Non-Rohs, Refurb — Zoll Circulation, Inc.10.7F PACKAGED ACCUTROL CATHETER — Zoll Circulation, Inc.ICY® Intravascular Heat Exchange Catheter Kit Surmodics Non Heparin — Zoll Circulation, Inc.Start-Up Kit Extended Length — Zoll Circulation, Inc.CATHETER INTRODUCER KIT, 14F — Zoll Circulation, Inc.Quattro, Heparin, Premium Kit, US — Zoll Circulation, Inc.RTX CIRCULATING CASSETTE WITH ELECTROLYTE — Zoll Circulation, Inc.Hospital Monitoring Interface Accessory — Zoll Circulation, Inc.ICY® Intravascular Heat Exchange Catheter Kit (Heparin) — Zoll Circulation, Inc.Cool Line® Intravascular Heat Exchange Catheter Kit (Applause) — Zoll Circulation, Inc.Cool Line® Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin — Zoll Circulation, Inc.CATHETER INTRODUCER KIT, 10.7F — Zoll Circulation, Inc.InnerCool RTx 14F Standard Catheter — Zoll Circulation, Inc.Thermogard HQTM Start-Up Kit — Zoll Circulation, Inc.QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Surmodics Non-Hep — Zoll Circulation, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
| 2021-08-06 | ZOLL Circulation, Inc. | Labeling update concerning potential leaks from the catheter or the start-up kit (SUK) tubing |
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