FDA 510(k) Application Details - K061710

Device Classification Name Catheter, Percutaneous

  More FDA Info for this Device
510(K) Number K061710
Device Name Catheter, Percutaneous
Applicant ST. JUDE MEDICAL
15900 VALLEY VIEW CT.
SYLMAR, CA 91342-3577 US
Other 510(k) Applications for this Company
Contact ADELE SHOUSTAL
Other 510(k) Applications for this Contact
Regulation Number 870.1250

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

  More FDA Info for this Product Code
Date Received 06/19/2006
Decision Date 07/14/2006
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