← FDA Medical Device Classifications

Catheter, Femoral

LFK · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5540

Classification

FDA Product Code

LFK

Device class

Class II — Moderate Risk (510(k) clearance required)

Regulation

21 CFR 876.5540

Review panel

GU

Medical specialty

Gastroenterology, Urology

Submission type

1

GMP exempt

N

Life sustaining

Y

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

16

Registered establishments

6

Source

Authoritative

FDA Device Classification database

Machine

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