FDA 510(k) Application Details - K190753

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K190753
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	Medtronic, Inc. (formerly d.b.a. ev3 Inc, Covidien llc.) 3033 Campus Drive, Suite N550 Plymouth, MN 55441 US Other 510(k) Applications for this Company
Contact	Breanna Fautsch 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	03/25/2019
Decision Date	04/23/2019
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