FDA 510(k) Application Details - K050038

Device Classification Name Catheter, Percutaneous

  More FDA Info for this Device
510(K) Number K050038
Device Name Catheter, Percutaneous
Applicant MEDTRONIC ENDOVASCULAR INNOVATIONS
3576 Unocal Place
Santa Rosa, CA 95403 US
Other 510(k) Applications for this Company
Contact WILLIE MITCHELL
Other 510(k) Applications for this Contact
Regulation Number 870.1250

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

  More FDA Info for this Product Code
Date Received 01/07/2005
Decision Date 04/13/2005
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