FDA 510(k) Application Details - K982187

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K982187
Device Name	Introducer, Catheter
Applicant	DAIG CORP. 14901 DEVEAU PLACE MINNETONKA, MN 55345-2126 US Other 510(k) Applications for this Company
Contact	DEAN BRUHN-DING 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	06/22/1998
Decision Date	09/16/1998
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