FDA 510(k) Application Details - K251344

Device Classification Name	Computer, Diagnostic, Programmable   More FDA Info for this Device
510(K) Number	K251344
Device Name	Computer, Diagnostic, Programmable
Applicant	Boston Scientific Corporation 4100 Hamline Avenue North Saint Paul, MN 55112-5798 US Other 510(k) Applications for this Company
Contact	Derek Charchuk Other 510(k) Applications for this Contact
Regulation Number	870.1425   More FDA Info for this Regulation Number
Classification Product Code	DQK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/30/2025
Decision Date	05/28/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review