510(k) K052952

CATHASSIST by Physician Technologies, Inc. — Product Code KNY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 2006
Date Received
October 20, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessories, Catheter, G-U
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type