FDA 510(k) Application Details - K955499

Device Classification Name Catheter, Intravascular Occluding, Temporary

  More FDA Info for this Device
510(K) Number K955499
Device Name Catheter, Intravascular Occluding, Temporary
Applicant LUCAS MEDICAL, INC.
1751 SOUTH DOUGLASS RD.
ANAHEIM, CA 92806 US
Other 510(k) Applications for this Company
Contact DANIEL R LUCAS
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 12/01/1995
Decision Date 02/28/1996
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