FDA 510(k) Application Details - K091825

Device Classification Name Wire, Guide, Catheter

  More FDA Info for this Device
510(K) Number K091825
Device Name Wire, Guide, Catheter
Applicant ABBOTT VASCULAR INC.
41888 MOTOR CAR PARKWAY
TEMECULA, CA 92591 US
Other 510(k) Applications for this Company
Contact MICHELE WALZ
Other 510(k) Applications for this Contact
Regulation Number 870.1330

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

  More FDA Info for this Product Code
Date Received 06/19/2009
Decision Date 09/25/2009
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