FDA 510(k) Application Details - K981782

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K981782
Device Name	Introducer, Catheter
Applicant	ARROW INTL., INC. 1600 PROVIDENCE HIGHWAY WALPOLE, MA 02081 US Other 510(k) Applications for this Company
Contact	BRADLEY J ENEGREN Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/20/1998
Decision Date	08/12/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review