FDA Device Intelligence
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Valve, Pressure Relief, Cardiopulmonary Bypass

FDA product code MNJ · Class 2 · Cardiovascular

0
Registered devices
66
Adverse events
1
Recalls
2
510(k) clearances

Recent recalls

DateFirmReason
2013-06-04Terumo Cardiovascular Systems CorporationOver-Pressure Safety Valves not cleared with an indication for use on the arterial side of the extracorporeal bypass circuit.

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