• 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 catheter, embolectomy
510(k) Number K113363
Device Name ANGIOJET SOLENT DISTA THROMBECTOMY SET
Original Applicant
MEDRAD, INC.
9055 evergreen blvd nw
minneapolis,  MN  55433 -8003
Original Contact mike burnside
Regulation Number870.5150
Classification Product Code
DXE  
Date Received11/15/2011
Decision Date 06/06/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-