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Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)

Page Type
Product Code
Definition
Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4100 Ventricular catheter

§ 882.4100 Ventricular catheter.

(a) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.

(b) Classification. Class II (performance standards).

Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents)

Page Type
Product Code
Definition
Used to gain access to the cavities of the brain for injection of material into or removal of material from the brain.
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.4100
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4100 Ventricular catheter

§ 882.4100 Ventricular catheter.

(a) Identification. A ventricular catheter is a device used to gain access to the cavities of the brain for injection of material into, or removal of material from, the brain.

(b) Classification. Class II (performance standards).