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Cannula, Ventricular

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
882.4060
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4060 Ventricular cannula

§ 882.4060 Ventricular cannula.

(a) Identification. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019]

Cannula, Ventricular

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K) Exempt
Device Classification
Class 1
Regulation Number
882.4060
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 882.4060 Ventricular cannula

§ 882.4060 Ventricular cannula.

(a) Identification. A ventricular cannula is a device used to puncture the ventricles of the brain for aspiration or for injection. This device is frequently referred to as a ventricular needle.

(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 882.9.

[44 FR 51730, Sept. 4, 1979, as amended at 65 FR 2319, Jan. 14, 2000; 84 FR 71815, Dec. 30, 2019]