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Clip, Vena-Cava

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Cardiovascular
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.3260
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.3260 Vena cava clip

§ 870.3260 Vena cava clip.

(a) Identification. A vena cava clip is an implanted extravascular device designed to occlude partially the vena cava for the purpose of inhibiting the flow of thromboemboli through that vessel.

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

Clip, Vena-Cava

Page Type
Product Code
Regulation Medical Specialty
Cardiovascular
Review Panel
Cardiovascular
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
870.3260
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
Yes
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 870.3260 Vena cava clip

§ 870.3260 Vena cava clip.

(a) Identification. A vena cava clip is an implanted extravascular device designed to occlude partially the vena cava for the purpose of inhibiting the flow of thromboemboli through that vessel.

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