510(k) K140733

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

K140733 is an FDA 510(k) premarket notification submitted by Boston Scientific Corporation for the device "CONSTELLATION MULTIPLE ELECTRODE RECORDING & PACING CATHETER". The FDA issued a decision of Substantially Equivalent on April 28, 2014. The device falls under product code MTD (Catheter, Intracardiac Mapping, High-Density Array), a Class II device regulated under 21 CFR 870.1220. Boston Scientific Corporation has at least 10 other 510(k) clearances on record.

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