HCI

14 FDA 510(k) clearances · Product code

FDA profile

Official device name

Applier, Aneurysm Clip

Device class

Class II (moderate risk)

Regulation

21 CFR 882.4175

Medical specialty

Neurology

Flags

Third-party review eligible

Adverse events (MAUDE)

1994: 1 · 2000: 1 · 2013: 27
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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