ClearanceBrief
510(k) K960280 ยท FPA Set, Administration, Intravascular

IVAC NEEDLE FREE VALVE ADMINISTRATION SETS

ApplicantY, San Diego CA, US
DecisionSubstantially Equivalent, Apr 4, 1996
ReceivedJan 19, 1996
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K960280

DateFirm and productCodeLinked 510(k)
Aug 2, 2021CAREFUSION
BD Extension Set SMALLBORE Tubing SmartSite VALVE, REF: 10010511; BD SmartSite Extension Set Needle-Free Valve, REF: 10010912; BD EXTENSION SET SMALLBORE TUBING DETACHABLE SmartSite VALVE, REF: 10010
Open, Classified		 FPANone listed
Aug 2, 2021CAREFUSION
BD Alaris Pump Infusion Buerette Set Smallbore Tubing Smartsite Port (Burette) 3 SmartSite Y-Sites, REF: 2441-0006
Open, Classified		 FPANone listed
Aug 2, 2021CAREFUSION
BD SmartSite, REF: 2000E CHINA; BD SmartSite Connector, REF: 2000E-04; BD SmartSite J-LOOP Extension Set One Needle Free Valve, REF: 20021E7D; BD SmartSite Extension Set One Needle Free Valve Slip Lue
Open, Classified		 FPANone listed
Nov 5, 2015CareFusion 303, Inc.
SmartSite Extension Set, Model No. 20029E. Used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Terminated		 FPANone listed
Feb 4, 2015CareFusion 303, Inc.
SmartSite Low Sorbing Infusion Set, Model No. 10015862 The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein.
Terminated		 FPANone listed
Apr 16, 2014CareFusion 303, Inc.
SmartSite Extension Set, Model No. 20029E, intravascular administration set.
Terminated		 FPANone listed
Feb 3, 2014CareFusion 303, Inc.
SmartSite Needleless Connector, Model No. 2000E The SmartSite Needleless Connectors are sterile, individually packaged connectors. The connectors are used to administer fluid and medications. The ne
Terminated		 FPANone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.