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Probe, Thermodilution

FDA product code KRB · Class 2 · Cardiovascular

133
Registered devices
340
Adverse events
4
Recalls
37
510(k) clearances

Devices with this code

SP5555-POLE MOUNTING BRACKET — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.PiCCO Catheter — Pulsion Medical Systems SECARESCAPE B850 — GE Healthcare Finland OyCO-SET+ — Edwards Lifesciences LLCPiCCO Catheter — Pulsion Medical Systems SENA — GE Medical Systems Information Technologies, Inc.CRITICATH SP5107S TD CATHETER — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.NA — GE Healthcare Finland OyCO-SET+ — Edwards Lifesciences LLCNA — GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.PiCCO catheter — Maquet Critical Care ABCO-SET+ — Edwards Lifesciences LLCICU Medical — ICU MEDICAL, INC.CARESCAPE B650 — GE Healthcare Finland OyCritikit™ — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.ICU Medical — ICU MEDICAL, INC.VolumeView — Edwards Lifesciences LLCCARESCAPE Software — GE Healthcare Finland OyCRITIKIT(TM) SP4572 — ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.NA — GE Healthcare Finland OyVOLUMEVIEW — Edwards Lifesciences LLCVOLUMEVIEW — Edwards Lifesciences LLCICU Medical — ICU MEDICAL, INC.PiCCO Catheter — Pulsion Medical Systems SE

Recent recalls

DateFirmReason
2018-10-05ICU Medical, Inc.Potential for leakage due to defect in the thermoset check valve component.
2018-10-05ICU Medical, Inc.Potential for leakage due to defect in the thermoset check valve component.
2018-10-05ICU Medical, Inc.Potential for leakage due to defect in the thermoset check valve component.
2014-11-04Pulsion Medical IncInternal testing and investigation of the packaging revealed cracks and holes in primary packaging

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.