510(k) K904787

CRI STEERABLE CATHETER CONTROL SYSTEM by Catheter Research C/O Burditt, Bowles & Radzius — Product Code DXX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1990
Date Received
October 23, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Catheter Control, Steerable
Device Class
Class II
Regulation Number
870.1290
Review Panel
CV
Submission Type