FDA 510(k) Application Details - K132947

Device Classification Name Catheter, Continuous Flush

  More FDA Info for this Device
510(K) Number K132947
Device Name Catheter, Continuous Flush
Applicant BOSTON SCIENTIFIC CORP.
ONE SCIMED PLACE
MAPLE GROVE, MN 55311 US
Other 510(k) Applications for this Company
Contact MAUREEN SUNDEEN
Other 510(k) Applications for this Contact
Regulation Number 870.1210

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

  More FDA Info for this Product Code
Date Received 09/19/2013
Decision Date 10/18/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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