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510(k) K123448

Device
AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH BALANCE BIOSURFACE, AFFINITY FLEXIBLE LUER LOCK ADAPTER WITH CARMEDA BIOACTIVE
Applicant
MEDTRONIC INC.
510(k) number
K123448
Product code
DTL  
Decision
Substantially Equivalent (SESE)
Decision date
2012-12-13
Date received
2012-11-08
Regulation
870.4290
Classification name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JULIA A NELSON
Address
7611 Northland Dr. Minneapolis MN US 55428 55428

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
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
K091634NMI FCNavilyst Medical, Inc.2010-03-01

Legacy Summary#

summary

FDA Review#

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