FDA 510(k) Application Details - K984482

Device Classification Name	Catheter, Percutaneous   More FDA Info for this Device
510(K) Number	K984482
Device Name	Catheter, Percutaneous
Applicant	ARTERIAL VASCULAR ENGINEERING MASSACHUSETTS, INC. 129 CONCORD RD. P.O. BOX 566 BILLERICA, MA 01821 US Other 510(k) Applications for this Company
Contact	NORMA J LEMAY 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	12/16/1998
Decision Date	07/30/1999
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