FDA 510(k) Application Details - K042194

Device Classification Name Catheter, Percutaneous

  More FDA Info for this Device
510(K) Number K042194
Device Name Catheter, Percutaneous
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVENUE NE
MINNEAPOLIS, MN 55432 US
Other 510(k) Applications for this Company
Contact LYNN JENSEN
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 08/12/2004
Decision Date 09/15/2004
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