FDA product code OKR

Ventricular Bypass (Assist) Device

Cardiovascular·Class 3·21 CFR 870.3545
US regulatory classifications
US Product Code (FDA)
OKR
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US Risk Class (FDA)
Class 3
US Regulation (CFR)
21 CFR 870.3545
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A ventricular bypass (assist) device is a device that assists the left or right ventricle in maintaining circulatory blood flow for <6 hours. The device is either totally or partially implanted in the body.

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About this record

Ventricular Bypass (Assist) Device is a medical device type in the Cardiovascular specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.