FDA 510(k) Application Details - K973013

Device Classification Name	Catheter, Angioplasty, Peripheral, Transluminal   More FDA Info for this Device
510(K) Number	K973013
Device Name	Catheter, Angioplasty, Peripheral, Transluminal
Applicant	VAS-CATH, INC. 8195 INDUSTRIAL BLVD. COVINGTON, GA 30014 US Other 510(k) Applications for this Company
Contact	DONNA J WILSON 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	08/13/1997
Decision Date	06/19/1998
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