FDA product code SEF

Central Venous Catheter With Manual Insertion System

General Hospital·Class 2·21 CFR 880.5200
US regulatory classifications
US Product Code (FDA)
SEF
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US Risk Class (FDA)
Class 2
US Regulation (CFR)
21 CFR 880.5200
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Medical specialty
General Hospital
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
Definition

A central venous catheter with manual insertion system is intended to provide short-term access (<30 days) to the central venous system. The manual insertion system is attached to the catheter and facilitates placement in the targeted vessel.

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About this record

Central Venous Catheter With Manual Insertion System is a medical device type in the General Hospital 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.