510(k) K200950

Ventricular Catheter by Aesculap, Inc. — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 8, 2020
Date Received
April 9, 2020
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type