FDA 510(k) Application Details - K974640

Device Classification Name	Dilator, Vessel, For Percutaneous Catheterization   More FDA Info for this Device
510(K) Number	K974640
Device Name	Dilator, Vessel, For Percutaneous Catheterization
Applicant	BOSTON SCIENTIFIC CORP. ONE BOSTON SCIENTIFIC PL. NATICK, MA 01760-1537 US Other 510(k) Applications for this Company
Contact	WANDA CARPINELLA Other 510(k) Applications for this Contact
Regulation Number	870.1310   More FDA Info for this Regulation Number
Classification Product Code	DRE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/1997
Decision Date	03/13/1998
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