FDA 510(k) Application Details - K152080

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K152080
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	Kaneka Corporation 1-12-32, Akasaka, Minato-ku Tokyo 107-6025 JP Other 510(k) Applications for this Company
Contact	Toshihiko Motomine 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	07/27/2015
Decision Date	09/24/2015
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