FDA 510(k) Application Details - K950156

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K950156
Device Name	Wire, Guide, Catheter
Applicant	ADVANCED CARDIOVASCULAR SYSTEMS, INC. 3200 LAKESIDE DR. P.O. BOX 58167 SANTA CLARA, CA US Other 510(k) Applications for this Company
Contact	J P PALIN Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/17/1995
Decision Date	04/05/1995
Decision	SE - Substantially Equivalent
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review