FDA 510(k) Application Details - K201377

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K201377
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	Cordis Corporation 14201 NW 60TH Ave Miami Lakes, FL 33014 US Other 510(k) Applications for this Company
Contact	Luis Davila Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	LIT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2020
Decision Date	10/09/2020
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