← FDA Medical Device Classifications

System, Perfusion, Kidney

KDN · Class II — Moderate Risk (510(k) clearance required) · Gastroenterology, Urology · 21 CFR 876.5880

Classification

FDA Product Code

KDN

Device class

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

Regulation

21 CFR 876.5880

Review panel

GU

Medical specialty

Gastroenterology, Urology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

N

Third-party review

Y

Market data

Cleared 510(k) submissions

42

Registered establishments

36

Source

Authoritative

FDA Device Classification database

Machine

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