FDA 510(k) Application Details - K071367

Device Classification Name Catheter, Intravascular Occluding, Temporary

  More FDA Info for this Device
510(K) Number K071367
Device Name Catheter, Intravascular Occluding, Temporary
Applicant LEMAITRE VASCULAR, INC.
63 2ND AVENUE
BURLINGTON, MA 01803 US
Other 510(k) Applications for this Company
Contact MINNIE MILDWOFF
Other 510(k) Applications for this Contact
Regulation Number 870.4450

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

  More FDA Info for this Product Code
Date Received 05/16/2007
Decision Date 08/29/2007
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