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510(k) K914987

Device
HIGH PRESSURE CONNECTING SETS, MODIFICATION
Applicant
E-Z-EM, INC.
510(k) number
K914987
Product code
DTL  
Decision
Substantially Equivalent (SESE)
Decision date
1992-05-20
Date received
1991-10-24
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
Statement
Third party reviewed
No

Applicant Contact#

Contact
MERRIBETH ADAMS
Address
P.O. Box 993 266 Queensbury Ave. Glens Falls NY US 12801 12801

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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#

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FDA Review#

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