← FDA Medical Device Classifications

Port & Catheter, Implanted, Subcutaneous, Intraventricular

LKG · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.5550

Classification

FDA Product Code

LKG

Device class

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

Regulation

21 CFR 882.5550

Review panel

HO

Medical specialty

Neurology

Submission type

1

GMP exempt

N

Life sustaining

N

Implant

Y

Third-party review

N

Market data

Cleared 510(k) submissions

8

Registered establishments

8

Source

Authoritative

FDA Device Classification database

Machine

JSON-LD · Markdown