• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name clip, implantable
510(k) Number K040832
Device Name C-PORT ANASTOMOSIS SYSTEM (DEPLOYMENT SYSTEM, CLIP, ACCESSORIES), MODEL FG-000050
Applicant
CARDICA, INC.
900 saginaw dr.
redwood city,  CA  94063
Applicant Contact sevrina ciucci
Correspondent
CARDICA, INC.
900 saginaw dr.
redwood city,  CA  94063
Correspodent Contact sevrina ciucci
Regulation Number878.4300
Classification Product Code
FZP  
Date Received03/31/2004
Decision Date 11/10/2005
Decision substantially equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-