510(k) K040812

DETECT SURGICAL PACING AND MAPPING TOOL by Medtronic Vascular — Product Code LDF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 2004
Date Received
March 29, 2004
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrode, Pacemaker, Temporary
Device Class
Class II
Regulation Number
870.3680
Review Panel
CV
Submission Type