LFK

16 FDA 510(k) clearances · Product code

FDA profile

Official device name

Catheter, Femoral

Device class

Class II (moderate risk)

Regulation

21 CFR 876.5540

Medical specialty

Gastroenterology, Urology

Flags

Implant · Life-sustaining

Adverse events (MAUDE)

1998: 5 · 1999: 2 · 2001: 3 · 2002: 2 · 2005: 3 · 2006: 3
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.

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