FDA 510(k) Application Details - K160004

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K160004
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	01/04/2016
Decision Date	04/29/2016
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