Central Venous Catheter With Manual Insertion System
SEF · Class II — Moderate Risk (510(k) clearance required) · General Hospital · 21 CFR 880.5200
Classification
FDA Product Code
SEF
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 880.5200
Review panel
HO
Medical specialty
General Hospital
Submission type
1
GMP exempt
N
Life sustaining
N
Implant
N
Third-party review
N
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.