510(k) K030005

VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETER ACCESSORY CABLES by Vanguard Medical Concepts, Inc. — Product Code DSA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 2003
Date Received
January 2, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cable, Transducer And Electrode, Patient, (Including Connector)
Device Class
Class II
Regulation Number
870.2900
Review Panel
CV
Submission Type