Home › Device types › NCX
System, Hypothermia, Intravenous, Cooling
FDA product code NCX · Class 2 · Cardiovascular
61
Registered devices
4,436
Adverse events
35
Recalls
26
510(k) clearances
Devices with this code
CATHETER INTRODUCER KIT, 14F — Zoll Circulation, Inc.SOLEX® Intravascular Heat Exchange Catheter Primum Kit Custom Luer Applause Hep — Zoll Circulation, Inc.Cool Line® Intravascular Heat Exchange Catheter Applause Custom Luer — Zoll Circulation, Inc.ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Surmodics Non Heparin — Zoll Circulation, Inc.RTX CIRCULATING CASSETTE WITH ELECTROLYTE — Zoll Circulation, Inc.SOLEX® Intravascular Heat Exchange Catheter US Kit Applause (Heparin) — Zoll Circulation, Inc.ICY® Intravascular Heat Exchange Catheter Kit Surmodics Non Heparin — Zoll Circulation, Inc.10.7F PACKAGED ACCUTROL CATHETER — Zoll Circulation, Inc.QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Surmodics Non-Hep — Zoll Circulation, Inc.ICY® Intravascular Heat Exchange Catheter Kit Custom Luer Applause (Heparin) — Zoll Circulation, Inc.Thermogard XP, Lang set C, Rohs — Zoll Circulation, Inc.Hospital Monitoring Interface Accessory — Zoll Circulation, Inc.ICY® Intravascular Heat Exchange Catheter Kit Applause (Heparin) — Zoll Circulation, Inc.QUATTRO® Intravascular Heat Exchange Catheter Kit Custom Luer Applause Heparin E — Zoll Circulation, Inc.Thermogard XP® — Zoll Circulation, Inc.ICY® Intravascular Heat Exchange Catheter Kit EU Applause Custom Luer (Heparin) — Zoll Circulation, Inc.Quattro, Heparin, Premium Kit, US — Zoll Circulation, Inc.Thermogard XP, Lang set A, Non-Rohs, Refurb — Zoll Circulation, Inc.Cool Line® Intravascular Heat Exchange Catheter Kit Non Heparin Custom Luer — Zoll Circulation, Inc.Cool Line® Intravascular Heat Exchange Catheter Kit Applause Custom Luer Heparin — Zoll Circulation, Inc.Thermogard HQTM Start-Up Kit — Zoll Circulation, Inc.ICY-3, Japan, Final Packaged Kit (Applause) — Zoll Circulation, Inc.InnerCool RTx 14F Standard Catheter — Zoll Circulation, Inc.Start-Up Kit Custom Luer — 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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