FDA 510(k) Application Details - K120229

Device Classification Name Catheter, Percutaneous

  More FDA Info for this Device
510(K) Number K120229
Device Name Catheter, Percutaneous
Applicant Codman & Shurtleff, Inc.
325 PARAMOUNT DR.
RAYNHAM, MA 02767-0350 US
Other 510(k) Applications for this Company
Contact CATHERINE KILSHAW
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 01/25/2012
Decision Date 02/24/2012
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