FDA 510(k) Application Details - K193279

Device Classification Name	Transducer, Pressure, Catheter Tip   More FDA Info for this Device
510(K) Number	K193279
Device Name	Transducer, Pressure, Catheter Tip
Applicant	Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311-1566 US Other 510(k) Applications for this Company
Contact	Kimberly Berg Other 510(k) Applications for this Contact
Regulation Number	870.2870   More FDA Info for this Regulation Number
Classification Product Code	DXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/27/2019
Decision Date	12/23/2019
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