510(k) K242003

XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set by Aesculap, Inc. — Product Code JXG

K242003 is an FDA 510(k) premarket notification submitted by Aesculap, Inc. for the device "XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set". The FDA issued a decision of Substantially Equivalent on December 16, 2024. 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
December 16, 2024
Date Received
July 9, 2024
Clearance Type
Traditional
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