510(k) K221827

Mais Central Venous Catheter by Saudi Mais Co. For Medical Products — Product Code FOZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 2023
Date Received
June 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Device Class
Class II
Regulation Number
880.5200
Review Panel
HO
Submission Type