510(k) K020728

MIETHKE SHUNT SYSTEM by Aesculap, Inc. — Product Code HCA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 2002
Date Received
March 6, 2002
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Ventricular
Device Class
Class II
Regulation Number
882.4100
Review Panel
NE
Submission Type