Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
 


New Search Back To Search Results
Device Classification Name Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
510(k) Number K073620
Device Name GUARDIAN HEMOSTASIS VALVE
Applicant
Zerusa Limited
219-220 Business Innovation
Centre Nuig,
Galway,  IE
Applicant Contact GER BRETT
Correspondent
Zerusa Limited
219-220 Business Innovation
Centre Nuig,
Galway,  IE
Correspondent Contact GER BRETT
Regulation Number870.4290
Classification Product Code
DTL  
Date Received12/26/2007
Decision Date 02/27/2008
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-