INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET— 510(k) K051499
Substantially EquivalentMedegen Medical Manufacturing Services
FDA 510(k) clearance K051499 for INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET, Substantially Equivalent on 2005-06-22. Applicant: Medegen Medical Manufacturing Services. Device class: 2.
Clearance details
- Applicant
- Medegen Medical Manufacturing Services
- Product code
- Code FPA
- Device class
- Class 2
- Regulation
- 21 CFR 880.5440
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Trabuco Canyon, CA, US
Recent devices under product code FPA
view all- K254123 — Ecomed Disposable Administration Sets
- K261530 — iiSure Infusion Set
- K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF, BA-70071-DF-120, FE01, FE04)
- K251375 — PuraCath Firefly Needleless Connector IT (9005)
- K251257 — nSet+ Stabilization Set [6426733] +2 more
More clearances from Medegen Medical Manufacturing Services
view allAdverse events under product code FPA
product code FPA- Death
- 95
- Injury
- 14,421
- Malfunction
- 125,815
- Other
- 30
- Total
- 140,361
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K051499
K-number listed on FDA's recall record- Z-2941-2026 — 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-C UDI-DI code: 10885403237218 Intravascular Administration Set and Extension Set used to administer fluids.
- Z-1752-2022 — BD MaxGuard Extension Set with 4-way stopcock, REF: M4058
- Z-1753-2022 — BD MaxGuard Extension Set, REF: ME1069
- Z-1754-2022 — BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106
- Z-1755-2022 — BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141
- Z-1756-2022 — BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold and removable 4-way stopcock, REF: MX4436
- Z-1757-2022 — BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059
- Z-1758-2022 — BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166
- Z-1759-2022 — BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171
- Z-1760-2022 — BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433
- Z-1464-2017 — MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305
- Z-1482-2017 — 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 catheter inserted into the patient s artery or vein. The extension sets may incorporate components that aid in the prevention of accidental needle sticks. The set s components are commonly found on intravascular administration sets and extension sets
- Z-0931-2014 — Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230.
- Z-0596-2013 — 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 provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0597-2013 — 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 provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0598-2013 — 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 therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0599-2013 — 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 provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0600-2013 — 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 infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0601-2013 — 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 infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
- Z-0602-2013 — 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 therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051499.
Data sourced from openFDA. This site is unofficial and independent of the FDA.