FDA.reportPublic FDA data

510(k) K122301

Device
GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVE
Applicant
VASCULAR SOLUTIONS ZERUSA LTD.
510(k) number
K122301
Product code
DTL  
Decision
Substantially Equivalent (SESE)
Decision date
2012-09-07
Date received
2012-08-01
Regulation
870.4290
Classification name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JENNIFER RUETHER
Address
6464 Sycamore Ct. Minneapolis MN US 55369 55369

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DTL  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K152528Attachable Cath Lab Hemostasis ValveGalt Medical Corp.2015-12-02
K143429Passage Hemostasis ValveMerit Medical Systems, Inc.2014-12-22
K140475ROTATING ADAPTERSMerit Medical Systems, Inc.2014-04-16
K131124COLIGNJilin Coronado Medical , Ltd.2013-08-28
K123448AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVEMedtronic, Inc.2012-12-13
K122811CONNECTOR COMPONENTS WITH BALANCE BIOSURFACEMedtronic, Inc.2012-10-12
K120069MEDLINE STOPCOCK AND MANIFOLDMedline Industries, Inc.2012-04-03
K113148E-PASSSynexmed(Shenzhen)Company Limited2012-02-28
K113845TUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACEMedtronic, Inc.2012-01-25
K113132DISPOSABLE HEMOSTATIC Y-CONNECTORSCoeur, Inc.2012-01-20
K113667CARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATINGEdwards Lifesciences, LLC2012-01-12
K101113GUARDIAN II NC HEMOSTASIS VALVEZerusa Limited2010-05-21
K093992TERUMO LAUER LOCK ADAPTERTerumo Cardiovascular Systems Corporation2010-05-19
K100319MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203LMerit Medical Systems, Inc.2010-04-28
K091634NMI FCNavilyst Medical, Inc.2010-03-01

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases