FDA 510(k) Application Details - K230620

Device Classification Name	Catheter, Intravascular, Diagnostic   More FDA Info for this Device
510(K) Number	K230620
Device Name	Catheter, Intravascular, Diagnostic
Applicant	Gentuity, LLC 142 North Road, Suite G Sudbury, MA 01776 US Other 510(k) Applications for this Company
Contact	Padmini Gagnon Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	DQO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/06/2023
Decision Date	08/08/2023
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