FDA 510(k) Application Details - K014041

Device Classification Name Device, Neurovascular Embolization

  More FDA Info for this Device
510(K) Number K014041
Device Name Device, Neurovascular Embolization
Applicant CORDIS NEUROVASCULAR
14000 N.W. 57TH COURT
MIAMI LAKES, FL 33014 US
Other 510(k) Applications for this Company
Contact ALINA CARABALLO
Other 510(k) Applications for this Contact
Regulation Number 882.5950

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

  More FDA Info for this Product Code
Date Received 12/07/2001
Decision Date 03/07/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee NE - Neurology
Review Advisory Committee NE - Neurology
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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