FDA 510(k) Application Details - K152161

Device Classification Name	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass   More FDA Info for this Device
510(K) Number	K152161
Device Name	Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant	Thoratec Corporation 6035 Stoneridge Drive Pleasanton, CA 94588 US Other 510(k) Applications for this Company
Contact	Lori DonDiego 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	08/03/2015
Decision Date	09/18/2015
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