FDA 510(k) Application Details - K963688

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K963688
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	CARDIOVASCULAR DYNAMICS, INC. 13900 ALTON PKWY. SUITE 122 IRVINE, CA 92618 US Other 510(k) Applications for this Company
Contact	MICHAEL CROCKER 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	09/16/1996
Decision Date	03/28/1997
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