FDA 510(k) Application Details - K143412

Device Classification Name Catheter, Percutaneous

  More FDA Info for this Device
510(K) Number K143412
Device Name Catheter, Percutaneous
Applicant CORDIS CORPORATION
6500 PASEO PADRE PKWY
FREMONT, CA 94555 US
Other 510(k) Applications for this Company
Contact BABU PERIASAMY
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 11/28/2014
Decision Date 01/14/2015
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