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510(k) K854562

Device
CONNECTOR, BLOOD TUBING, INFUSION T. INTRAVENOUS I
Applicant
MEDELEC INTL. CORP.
510(k) number
K854562
Product code
BRZ  
Decision
Substantially Equivalent (SESE)
Decision date
1986-01-09
Date received
1985-11-14
Regulation
880.5440
Classification name
Set, Blood Transfusion
Medical specialty
General Hospital
Review panel
General Hospital
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
OSCAR D DOCAL
Address
One Lincoln Rd., Suite 304 Miami Beach FL US 33139 33139

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code BRZ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K220558Blood Administration SetsBaxter Healthcare Corporation2022-11-17
K210335Blood Administration SetBaxter Healthcare Corporation2021-06-10
K132905200 MICRON BLOOD COMPONENT FILTER AND SYRINGE ADAPTERArteriocyte Medical Systems, Inc.2013-10-04
K083349BLOOD TRANSFUSION SETShan Dong Wei Gao Group Medical Polymer Products2009-04-10
K073339BLOOD COMPONENT RECIPIENT SET WITH STANDARD SIZE FILTER AND INFUSION SET WITH SIDE ARM LUER CONNECTORFenwal, Inc.2008-03-03
K041496PENTATRASFU BLOOD TRANSFUSION SETSPentaferte S.P.A2005-06-30
K05080530 ML OR 60 ML PEDI-SYRINGE FILTERBlood Products Specialties, LLC2005-06-20
K050115BLOOD HAND PUMP ADMINISTRATION SETCardinal Health, Alaris Products2005-04-01
K023039BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015Tuta Healthcare Pty Limited2002-11-07
K000685CHARTER MEDICAL NEONATAL SYRINGE SETCharter Medical, Ltd.2000-08-15
K993120MODIFIED BLOOD RECIPIENT SETBaxter Healthcare Corp1999-11-17
K972843PROTOS BLOOD TRANSFUSION SETGlobe Ent., Inc.1997-12-16
K940074Y-TYPE BLOOD ADMINISTRATION SETPuritas Health Care, Inc.1994-04-21
K940055MULTISETPuritas Health Care, Inc.1994-04-15
K921595Y-TYPE BLOOD ADMINISTRATION SET MODEL #HT-TR2Haemotronic, Inc.1992-12-24

Legacy Summary#

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FDA Review#

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