ClearanceBrief
510(k) K051499 ยท FPA Set, Administration, Intravascular

INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET

ApplicantMedegen Medical Manufacturing Services, Trabuco Canyon CA, US
DecisionSubstantially Equivalent, Jun 22, 2005
ReceivedJun 7, 2005
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K051499

DateFirm and productCodeLinked 510(k)
Aug 13, 2026BD SWITZERLAND SARL
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext Set w/Needleless and Y-Site REF MPX5305-C UDI-DI code: 10885403274619 9 IN Extension Set w/Max Y REF MPX5300-
Open, Classified
FPANone listed
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
Open, Classified
FPANone listed
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set, REF: ME1069
Open, Classified
FPANone listed
Sep 13, 2022CAREFUSION
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
Open, Classified
FPANone listed
Sep 13, 2022CAREFUSION
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
Open, Classified
FPANone listed
Sep 13, 2022CAREFUSION
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
Open, Classified
FPANone listed
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
Open, Classified
FPANone listed
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
Open, Classified
FPANone listed
Sep 13, 2022CAREFUSION
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
Open, Classified
FPANone listed
Sep 13, 2022CAREFUSION
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
Open, Classified
FPANone listed
Feb 28, 2017CareFusion 303, Inc.
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
Terminated
FPANone listed
Feb 28, 2017CareFusion 303, Inc.
MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension sets are used to administer fluids from a container to a patient s vascular system through a needle or cathete
Terminated
FPANone listed
Feb 4, 2014CareFusion 303, Inc.
Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
Terminated
FPANone listed
Dec 20, 2012Medrad Inc
Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to pro
Terminated
FPANone listed
Dec 20, 2012Medrad Inc
Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to pr
Terminated
FPANone listed
Dec 20, 2012Medrad Inc
Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion th
Terminated
FPANone listed
Dec 20, 2012Medrad Inc
Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provid
Terminated
FPANone listed
Dec 20, 2012Medrad Inc
Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusio
Terminated
FPANone listed
Dec 20, 2012Medrad Inc
Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infus
Terminated
FPANone listed
Dec 20, 2012Medrad Inc
Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion
Terminated
FPANone listed
Dec 20, 2012Medrad Inc
Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide inf
Terminated
FPANone listed
Dec 20, 2012Medrad Inc
Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infus
Terminated
FPANone listed
Dec 20, 2012Medrad Inc
Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion
Terminated
FPANone listed
Jun 29, 2011Carefusion 303, Inc.
MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Product Usage: The MaxPlus bifuse extension sets are used administer fluids from a container to a patient's vas
Terminated
FPANone listed

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