• 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 adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
510(k) Number K122301
Models 8210,8211, 8215,8216
Device Name GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
Original Applicant
VASCULAR SOLUTIONS ZERUSA LTD.
6464 sycamore court
minneapolis,  MN  55369
Original Contact jennifer ruether
Regulation Number870.4290
Classification Product Code
DTL  
Date Received08/01/2012
Decision Date 09/07/2012
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
Recalls CDRH Recalls
-
-