• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name device, vascular, for promoting embolization
510(k) Number K113658
Models 9-AVP038-004; AVP038-005, 9-AVP038-006;, 9-AVP38-007; 9-AVP038-008 9FIVE (5) MODEL NUMBERS)
Device Name AMPLATZER VASCULAR PLUG 4
Original Applicant
AGA MEDICAL CORP.
5050 nathan lane north
plymouth,  MN  55442
Original Contact sherry kollmann
Regulation Number870.3300
Classification Product Code
KRD  
Date Received12/12/2011
Decision Date 06/12/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Cardiovascular
Review Advisory Committee Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-