MSB

13 FDA 510(k) clearances · Product code

FDA profile

Official device name

System And Accessories, Isolated Heart, Transport And Preservation

Device class

Class II (moderate risk)

Regulation

21 CFR 876.5880

Medical specialty

Gastroenterology, Urology

Adverse events (MAUDE)

2006: 8 · 2007: 6 · 2008: 3 · 2009: 7 · 2012: 8 · 2014: 18
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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