510(k) K191470

C-CAT Anaesthesia Catheter kit by Cimpax Aps — Product Code BSO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 25, 2019
Date Received
June 3, 2019
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Conduction, Anesthetic
Device Class
Class II
Regulation Number
868.5120
Review Panel
AN
Submission Type