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Central Venous Catheter With Manual Insertion System

FDA product code SEF · 1 cleared devices

Class 2 General Hospital
Regulation
21 CFR 880.5200
Review panel
HO
Implant
No
Life sustaining
No
Third party review
No
GMP exempt
No
Clearance span
2025-04-09 – 2025-04-09

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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