FDA 510(k) Application Details - K150186

Device Classification Name Introducer, Catheter

  More FDA Info for this Device
510(K) Number K150186
Device Name Introducer, Catheter
Applicant BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311 US
Other 510(k) Applications for this Company
Contact KURTIS HUNSBERGER
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 01/27/2015
Decision Date 06/05/2015
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



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