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Agents, Embolic, For Treatment Of Uterine Fibroids

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.3300
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.3300 Vascular embolization device

§ 870.3300 Vascular embolization device.

(a) Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

(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 § 870.1(e).

[69 FR 77899, Dec. 29, 2004]

Agents, Embolic, For Treatment Of Uterine Fibroids

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Obstetrical and Gynecological
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.3300
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.3300 Vascular embolization device

§ 870.3300 Vascular embolization device.

(a) Identification. A vascular embolization device is an intravascular implant intended to control hemorrhaging due to aneurysms, certain types of tumors (e.g., nephroma, hepatoma, uterine fibroids), and arteriovenous malformations. This does not include cyanoacrylates and other embolic agents, which act by polymerization or precipitation. Embolization devices used in neurovascular applications are also not included in this classification, see § 882.5950 of this chapter.

(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 § 870.1(e).

[69 FR 77899, Dec. 29, 2004]