510(k) K051499 ยท FPA Set, Administration, Intravascular
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
| Applicant | Medegen Medical Manufacturing Services, Trabuco Canyon CA, US |
| Decision | Substantially Equivalent, Jun 22, 2005 |
| Received | Jun 7, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K051499
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 13, 2026 | BD 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 |
FPA | None listed |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 Open, Classified |
FPA | None listed |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set, REF: ME1069 Open, Classified |
FPA | None listed |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106 Open, Classified |
FPA | None listed |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141 Open, Classified |
FPA | None listed |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436 Open, Classified |
FPA | None listed |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 Open, Classified |
FPA | None listed |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166 Open, Classified |
FPA | None listed |
| Sep 13, 2022 | CAREFUSION BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171 Open, Classified |
FPA | None listed |
| Sep 13, 2022 | CAREFUSION BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 Open, Classified |
FPA | None listed |
| Feb 28, 2017 | CareFusion 303, Inc. MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305 Terminated |
FPA | None listed |
| Feb 28, 2017 | CareFusion 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 |
FPA | None listed |
| Feb 4, 2014 | CareFusion 303, Inc. Trifurcated Extension Set, model no. ME 1224.
Trifurcated Extension Set, model no. MP 9230. Terminated |
FPA | None listed |
| Dec 20, 2012 | Medrad 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 |
FPA | None listed |
| Dec 20, 2012 | Medrad 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 |
FPA | None listed |
| Dec 20, 2012 | Medrad 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 |
FPA | None listed |
| Dec 20, 2012 | Medrad 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 |
FPA | None listed |
| Dec 20, 2012 | Medrad 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 |
FPA | None listed |
| Dec 20, 2012 | Medrad 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 |
FPA | None listed |
| Dec 20, 2012 | Medrad 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 |
FPA | None listed |
| Dec 20, 2012 | Medrad 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 |
FPA | None listed |
| Dec 20, 2012 | Medrad 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 |
FPA | None listed |
| Dec 20, 2012 | Medrad 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 |
FPA | None listed |
| Jun 29, 2011 | Carefusion 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 |
FPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.