FDA 510(k) Application Details - K062752

Device Classification Name Catheter, Continuous Flush

  More FDA Info for this Device
510(K) Number K062752
Device Name Catheter, Continuous Flush
Applicant MERCATOR MEDSYSTEMS, INC.
3077 TEAGARDEN STREET
SAN LEANDRO, CA 94577-5720 US
Other 510(k) Applications for this Company
Contact KIRK SEWARD
Other 510(k) Applications for this Contact
Regulation Number 870.1210

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

  More FDA Info for this Product Code
Date Received 09/14/2006
Decision Date 12/07/2006
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 Y
Expedited Review



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