FDA 510(k) Application Details - K040118

Device Classification Name

  More FDA Info for this Device
510(K) Number K040118
Device Name VASCULAR SOLUTIONS D-STAT DRY HEMOSTATIC BANDAGE, THE D-STAT RADIAL HEMOSTATIC BAND AND THE D-STAT 2 DRY HEMOSTATIC
Applicant VASCULAR SOLUTIONS, INC.
6464 SYCAMORE COURT
MINNEAPOLIS, MN 55369 US
Other 510(k) Applications for this Company
Contact GREGORY W SACHS
Other 510(k) Applications for this Contact
Regulation Number

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

  More FDA Info for this Product Code
Date Received 01/20/2004
Decision Date 02/12/2004
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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