Atlas FDA

INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET

FDA 510(k) clearance K051499 · decided 2005-06-22

Clearance details

K-number
K051499
Device name
INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET
Applicant
Medegen Medical Manufacturing Services
Decision
Substantially Equivalent
Date received
2005-06-07
Decision date
2005-06-22
Days to decision
15 days
Clearance type
Traditional
Product code
FPA
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Trabuco Canyon, CA, US
Third-party review
Yes
Expedited review
No

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Recalls involving this device

RecordFirmDate
60 In Non-DEHP Minibore Extension Set RES ME2010 UDI-DI code: 10885403236235 MaxPlus Ext S recall (Z-2941-2026)BD SWITZERLAND SARL2026-08-13
BD MaxGuard Extension Set with 4-way stopcock, REF: M4058 recall (Z-1752-2022)CAREFUSION2022-09-13
BD MaxGuard Extension Set, REF: ME1069 recall (Z-1753-2022)CAREFUSION2022-09-13
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS106 recall (Z-1754-2022)CAREFUSION2022-09-13
BD MaxGuard Flow Controller Extension Set with Needleless Y-Site, REF: MFS141 recall (Z-1755-2022)CAREFUSION2022-09-13
BD MaxGuard Drop Administration set with 3 Needleless Y-Sites Removable 3-port Manifold an recall (Z-1756-2022)CAREFUSION2022-09-13
BD MaxGuard Extension Set with 2 Needleless Y-Site, REF: MX9059 recall (Z-1757-2022)CAREFUSION2022-09-13
BD MaxGuard Extension Set with 0.2 Micron Filter and Needleless Y-Site, REF: MX9166 recall (Z-1758-2022)CAREFUSION2022-09-13
BD MaxGuard Extension Set with 1.2 Micron Filter and Needleless Y-Site, REF: MX9171 recall (Z-1759-2022)CAREFUSION2022-09-13
BD MaxGuard 15 Drop Administration Set with 4 Needleless Y-Sites, REF: MX9433 recall (Z-1760-2022)CAREFUSION2022-09-13
MaxGuard Extension Set with Injection Site and 0.2 micron filter, Model No. ME3305 recall (Z-1464-2017)CareFusion 303, Inc.2017-02-28
MaxGuard Extension Set, Model No. ME2064, MP9009C, MP9209, MP9254C The MaxGuard extension recall (Z-1482-2017)CareFusion 303, Inc.2017-02-28
Trifurcated Extension Set, model no. ME 1224. Trifurcated Extension Set, model no. MP 9230 recall (Z-0931-2014)CareFusion 303, Inc.2014-02-04
Medrad(R) Continuum MR Infusion System Standard Administration Kit Peristaltic Pump System recall (Z-0596-2013)Medrad Inc2012-12-20
Medrad(R) Continuum MR Infusion System Secondary Administration Kit Peristaltic Pump Syste recall (Z-0597-2013)Medrad Inc2012-12-20
Medrad(R) Continuum MR Infusion System Primary Set Peristaltic Pump System designed for pa recall (Z-0598-2013)Medrad Inc2012-12-20
Medrad(R) Continuum MR Infusion System Primary VSA Stopcock Set Peristaltic Pump System de recall (Z-0599-2013)Medrad Inc2012-12-20
Medrad(R) Continuum MR Infusion System Primary VSA Set Peristaltic Pump System designed fo recall (Z-0600-2013)Medrad Inc2012-12-20
Medrad(R) Continuum MR Infusion System Primary Spike Set Peristaltic Pump System designed recall (Z-0601-2013)Medrad Inc2012-12-20
Medrad(R) Continuum MR Infusion System Secondary Set Peristaltic Pump System designed for recall (Z-0602-2013)Medrad Inc2012-12-20
Medrad(R) Continuum MR Infusion System Secondary Spike Set Peristaltic Pump System designe recall (Z-0603-2013)Medrad Inc2012-12-20
Medrad(R) Continuum MR Infusion System Secondary VSA Set Peristaltic Pump System designed recall (Z-0604-2013)Medrad Inc2012-12-20
Medrad(R) Continuum MR Infusion System Side Step Set Peristaltic Pump System designed for recall (Z-0605-2013)Medrad Inc2012-12-20
MaxPlus bifuse extension set (minibore) needleless connectors, Model Number: MP9232-C Prod recall (Z-2707-2011)Carefusion 303, Inc.2011-06-29