FDA 510(k) Application Details - K032312

Device Classification Name Catheter, Percutaneous

  More FDA Info for this Device
510(K) Number K032312
Device Name Catheter, Percutaneous
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVENUE N.
FRIDLEY, MN 55432-3576 US
Other 510(k) Applications for this Company
Contact KRISTINA MOLLNER
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 07/28/2003
Decision Date 10/21/2003
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