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DTL — Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass Class II

FDA Device Classification

Classification Details

Product Code
DTL
Device Class
Class II
Regulation Number
870.4290
Submission Type
Review Panel
CV
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K152528galt medicalAttachable Cath Lab Hemostasis ValveDecember 2, 2015
K143429merit medical systemsPassage Hemostasis ValveDecember 22, 2014
K140475merit medical systemsROTATING ADAPTERSApril 16, 2014
K131124jilin coronado medicalCOLIGNAugust 28, 2013
K123448medtronicAFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LDecember 13, 2012
K122811medtronicCONNECTOR COMPONENTS WITH BALANCE BIOSURFACEOctober 12, 2012
K122301vascular solutions zerusaGUARDIAN II HEMOSTASIS VALVE GUARDIAN II NC HEMOSTASIS VALVESeptember 7, 2012
K120069medline industriesMEDLINE STOPCOCK AND MANIFOLDApril 3, 2012
K113148synexmed(shenzhen)company limitedE-PASSFebruary 28, 2012
K113845medtronicTUBING, CONMNECTORS, AND ACCESSORIES WIT BALANCE BIOSURFACEJanuary 25, 2012
K113132coeurDISPOSABLE HEMOSTATIC Y-CONNECTORSJanuary 20, 2012
K113667edwards lifesciencesCARDIOPLEGIA DELIVERY SETS CARDIOPLEGIA DELIVERY SETS WITH DURAFLO COATINGJanuary 12, 2012
K101113zerusa limitedGUARDIAN II NC HEMOSTASIS VALVEMay 21, 2010
K093992terumo cardiovascular systems corporationTERUMO LAUER LOCK ADAPTERMay 19, 2010
K100319merit medical systemsMERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHApril 28, 2010
K091634navilyst medicalNMI FCMarch 1, 2010
K092563vascular solutionsGATOR CLIPSEAL PLUGNovember 4, 2009
K092711zerusa limitedGUARDIAN II HEMOSTASIS VALVEOctober 1, 2009
K080472sedatSEDAT MYSHELL LITEApril 23, 2008
K073260device partners internationalLIISA LEVER INTEGRATED INTERVENTIONAL SYSTEM ADAPTER, MODEL VSL-109March 13, 2008