DeviceClearance

Product code SEF— General Hospital

CentroVena Central Venous Catheter (CVC) with the CentroVena One Insertion System

Classification name
Central Venous Catheter With Manual Insertion System
Device class
Class 2
Regulation
21 CFR 880.5200
Advisory panel
General Hospital
Total cleared
1
First cleared
Most recent

FDA classification 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.”

— U.S. Food and Drug Administration, device classification record for product code SEF under 21 CFR 880.5200, via openFDA

Market context for product code SEF

FDA has cleared 1 device under product code SEF, all in 2025, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Top applicants under product code SEF

Recent clearances under product code SEF

Data sourced from openFDA. This site is unofficial and independent of the FDA.