FDA 510(k) Application Details - K021630

Device Classification Name Catheter, Biliary, Diagnostic

  More FDA Info for this Device
510(K) Number K021630
Device Name Catheter, Biliary, Diagnostic
Applicant BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311-1566 US
Other 510(k) Applications for this Company
Contact TODD KORNMANN
Other 510(k) Applications for this Contact
Regulation Number 876.5010

  More FDA Info for this Regulation Number
Classification Product Code FGE
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 05/17/2002
Decision Date 10/25/2002
Decision SESU - SE - WITH LIMITATIONS
Classification Advisory Committee GU - Gastroenterology & Urology
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact