MZQ

2 FDA 510(k) clearances · Product code

FDA profile

Official device name

Balloon, Detachable, For Neurovascular Occlusion

Device class

Class II (moderate risk)

Regulation

21 CFR 882.5950

Medical specialty

Neurology

Flags

Implant · Life-sustaining

Adverse events (MAUDE)

1999: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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