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Probe, Thermodilution
FDA product code KRB · Class 2 · Cardiovascular
137
Registered devices
346
Adverse events
4
Recalls
37
510(k) clearances
Devices with this code
Safewedge(TM) Relief Valve Device — BIOPTIMAL INTERNATIONAL PTE. LTD.NA — GE Medical Systems Information Technologies, Inc.CARESCAPE B450 — GE Healthcare Finland OyVolumeView — Edwards Lifesciences LLCVOLUMEVIEW — Edwards Lifesciences LLCNA — GE Healthcare Finland OyVOLUMEVIEW — Edwards Lifesciences LLCPiCCO Catheter — Pulsion Medical Systems SEPiCCO catheter — Maquet Critical Care ABNA — GE Medical Systems Information Technologies, Inc.CARESCAPE — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.PiCCO Monitoring Kit — Pulsion Medical Systems SECARESCAPE — GE Healthcare Finland OyPiCCO Monitoring Kit — Pulsion Medical Systems SECRITICATH™ SP5107H TD CATHETER — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.CO-SET+ — Edwards Lifesciences LLCPiCCO catheter — Maquet Critical Care ABVOLUMEVIEW — Edwards Lifesciences LLCPiCCO Catheter — Pulsion Medical Systems SECARESCAPE B650 — GE Healthcare Finland OyCARESCAPE — GE Healthcare Finland OyCO-SET+ — Edwards Lifesciences LLCInjectate temperature sensor housing — Pulsion Medical Systems SEVOLUMEVIEW — Edwards Lifesciences LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-10-05 | ICU Medical, Inc. | Potential for leakage due to defect in the thermoset check valve component. |
| 2018-10-05 | ICU Medical, Inc. | Potential for leakage due to defect in the thermoset check valve component. |
| 2018-10-05 | ICU Medical, Inc. | Potential for leakage due to defect in the thermoset check valve component. |
| 2014-11-04 | Pulsion Medical Inc | Internal testing and investigation of the packaging revealed cracks and holes in primary packaging |
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