FDA 510(k) Application Details - K003719

Device Classification Name Stripper, Artery, Intraluminal

  More FDA Info for this Device
510(K) Number K003719
Device Name Stripper, Artery, Intraluminal
Applicant VASCULAR ARCHITECTS, INC.
1830 BERING DR.
SAN JOSE, CA 95112-4226 US
Other 510(k) Applications for this Company
Contact JEAN M CAILLOUETTE
Other 510(k) Applications for this Contact
Regulation Number 870.4875

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

  More FDA Info for this Product Code
Date Received 12/04/2000
Decision Date 02/28/2001
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