FDA 510(k) Application Details - K120707

Device Classification Name Catheter, Percutaneous

  More FDA Info for this Device
510(K) Number K120707
Device Name Catheter, Percutaneous
Applicant VASCULAR SOLUTIONS, INC.
6464 Sycamore Court North
Minneapolis, MN 55369 US
Other 510(k) Applications for this Company
Contact ELLIE GILLESPIE
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 03/08/2012
Decision Date 05/15/2012
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