510(k) K140733

CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER by Boston Scientific Corporation — Product Code MTD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 28, 2014
Date Received
March 24, 2014
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intracardiac Mapping, High-Density Array
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type