510(k) K200950

Ventricular Catheter by Aesculap, Inc. — Product Code JXG

K200950 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "Ventricular Catheter". The FDA issued a decision of Substantially Equivalent on May 8, 2020. The device falls under product code JXG (Shunt, Central Nervous System And Components), a Class II device regulated under 21 CFR 882.5550. Aesculap, Inc. has at least 10 other 510(k) clearances on record.

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