FDA product code SEU

Peripheral Temporary And Retrievable Stent System

Cardiovascular·Class 2·21 CFR 870.5110
US regulatory classifications
US Product Code (FDA)
SEU
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 870.5110
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Medical specialty
Cardiovascular
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A peripheral temporary and retrievable stent system is a temporary scaffold placed into the peripheral vasculature via a delivery catheter system for treating stenotic lesions. The device is designed to be retrieved and removed following successful treatment.

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About this record

Peripheral Temporary And Retrievable Stent System 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.