← FDA Medical Device Classifications

Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)

NHC · Class II — Moderate Risk (510(k) clearance required) · Neurology · 21 CFR 882.4100

Classification

FDA Product Code
NHC
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 882.4100
Review panel
NE
Medical specialty
Neurology
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
Y
Third-party review
N

Definition

Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.

Market data

Cleared 510(k) submissions
3
Registered establishments
3

Source

Authoritative
FDA Device Classification database
Machine
JSON-LD · Markdown