• 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 | 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 prosthesis, vascular graft, of 6mm and greater diameter
510(k) Number K122138
Device Name ATRIUM FLIXENE IFG VASCULAR GRAFT
Original Applicant
ATRIUM MEDICAL CORP.
5 wentworth dr
hudson,  NH  03051
Original Contact megan mccagh
Regulation Number870.3450
Classification Product Code
DSY  
Date Received07/19/2012
Decision Date 08/17/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-