FDA 510(k) Application Details - K022135

Device Classification Name	Catheter, Urological   More FDA Info for this Device
510(K) Number	K022135
Device Name	Catheter, Urological
Applicant	BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 US Other 510(k) Applications for this Company
Contact	JANET A MCGRATH Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	KOD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	07/01/2002
Decision Date	09/13/2002
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review