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510(k) K073620

Device
GUARDIAN HEMOSTASIS VALVE
Applicant
ZERUSA LIMITED
510(k) number
K073620
Product code
DTL  
Decision
Substantially Equivalent (SESE)
Decision date
2008-02-27
Date received
2007-12-26
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
GER BRETT
Address
219-220 Business Innovation Centre Nuig, Galway IE

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
K122301GUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVEVascular Solutions Zerusa , Ltd.2012-09-07
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

Legacy Summary#

summary

FDA Review#

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