FDA 510(k) Application Details - K142301

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K142301
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	COOK VASCULAR, INC. 1186 MONTGOMERY LANE VANDERGRIFT, PA 15690 US Other 510(k) Applications for this Company
Contact	Thomas J. Kardos Other 510(k) Applications for this Contact
Regulation Number	870.1310   More FDA Info for this Regulation Number
Classification Product Code	DRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/18/2014
Decision Date	11/12/2014
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