FDA 510(k) Application Details - K994229

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K994229
Device Name	Catheter, Percutaneous
Applicant	ADVANCED CARDIOVASCULAR SYSTEMS, INC. 26531 YNEZ RD. TEMECULA, CA 92591 US Other 510(k) Applications for this Company
Contact	STACEY SIMON Other 510(k) Applications for this Contact
Regulation Number	870.1250   More FDA Info for this Regulation Number
Classification Product Code	DQY Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/1999
Decision Date	02/25/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review