FDA 510(k) Application Details - K984435

Device Classification Name Ring, Annuloplasty

  More FDA Info for this Device
510(K) Number K984435
Device Name Ring, Annuloplasty
Applicant MEDTRONIC VASCULAR
7000 CENTRAL AVE. NE
MINNEAPOLIS, MN 55432-3576 US
Other 510(k) Applications for this Company
Contact JULIE SHERMAN
Other 510(k) Applications for this Contact
Regulation Number 870.3800

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

  More FDA Info for this Product Code
Date Received 12/11/1998
Decision Date 01/07/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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