FDA 510(k) Application Details - K150262

Device Classification Name Filter, Intravascular, Cardiovascular

  More FDA Info for this Device
510(K) Number K150262
Device Name Filter, Intravascular, Cardiovascular
Applicant Volcano Corporation
3721 Valley Centre Dr., Suite 500
San Diego, CA 92130 US
Other 510(k) Applications for this Company
Contact Elaine Alan
Other 510(k) Applications for this Contact
Regulation Number 870.3375

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

  More FDA Info for this Product Code
Date Received 02/04/2015
Decision Date 04/03/2015
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