FDA 510(k) Application Details - K040100

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K040100
Device Name	Wire, Guide, Catheter
Applicant	ARROW INTL., INC. 2400 BERNVILLE RD. P.O. BOX 12888 READING, PA 19605 US Other 510(k) Applications for this Company
Contact	WILLIAM G MCLAIN 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	01/20/2004
Decision Date	03/01/2004
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