FDA Device Intelligence
HomeDevice types › DTY

Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

FDA product code DTY · Class 2 · Cardiovascular

9
Registered devices
341
Adverse events
2
Recalls
8
510(k) clearances

Devices with this code

Recent recalls

DateFirmReason
2010-11-01Terumo Cardiovascular Systems CorporationInaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be ina
2010-11-01Terumo Cardiovascular Systems CorporationInaccurate result. Possibility for displayed values for potassium, CO2, hematocrit, O2 saturation, pH, hemoglobin and other measured blood parameters to be ina

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