FDA 510(k) Application Details - K133681

Device Classification Name Device, Percutaneous Retrieval

  More FDA Info for this Device
510(K) Number K133681
Device Name Device, Percutaneous Retrieval
Applicant VOLCANO CORPORATION
1 FORTUNE DR
BILLERICA, MA 01821 US
Other 510(k) Applications for this Company
Contact ELISA HEBB
Other 510(k) Applications for this Contact
Regulation Number 870.5150

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

  More FDA Info for this Product Code
Date Received 12/02/2013
Decision Date 01/30/2014
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