Last synced on 27 January 2023 at 11:04 pm

Balloon, Detachable, For Neurovascular Occlusion

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5950
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 882.5950 Neurovascular embolization device

§ 882.5950 Neurovascular embolization device.

(a) Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.

(b) Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).

[69 FR 77900, Dec. 29, 2004]

Balloon, Detachable, For Neurovascular Occlusion

Page Type
Product Code
Regulation Medical Specialty
Neurology
Review Panel
Neurology
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
882.5950
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
Yes
Third Party Review
Not Third Party Eligible

CFR § 882.5950 Neurovascular embolization device

§ 882.5950 Neurovascular embolization device.

(a) Identification. A neurovascular embolization device is an intravascular implant intended to permanently occlude blood flow to cerebral aneurysms and cerebral ateriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in other vascular applications are also not included in this classification, see § 870.3300.

(b) Classification. Class II (special controls.) The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Vascular and Neurovascular Embolization Devices.” For availability of this guidance document, see § 882.1(e).

[69 FR 77900, Dec. 29, 2004]