FDA 510(k) Application Details - K211375

Device Classification Name	Catheter, Electrode Recording, Or Probe, Electrode Recording   More FDA Info for this Device
510(K) Number	K211375
Device Name	Catheter, Electrode Recording, Or Probe, Electrode Recording
Applicant	Boston Scientific Corporation 4100 Hamline Ave North St. Paul, MN 55112-5798 US Other 510(k) Applications for this Company
Contact	Donall Hosna Other 510(k) Applications for this Contact
Regulation Number	870.1220   More FDA Info for this Regulation Number
Classification Product Code	DRF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/04/2021
Decision Date	09/10/2021
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review