FDA 510(k) Application Details - K201100

Device Classification Name	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K201100
Device Name	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant	Medtronic Inc. 8200 Coral Sea St. NE Mounds Views, MN 55112 US Other 510(k) Applications for this Company
Contact	Juli Rubin Other 510(k) Applications for this Contact
Regulation Number	870.4210   More FDA Info for this Regulation Number
Classification Product Code	DWF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2020
Decision Date	07/15/2021
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