ClearanceBrief
510(k) K011905 ยท DQX Wire, Guide, Catheter

SNIPER ELITE MODEL-OR-E3872XX SERIES

ApplicantMaxxim Medical, Athens TX, US
DecisionSubstantially Equivalent, Aug 28, 2001
ReceivedJun 19, 2001
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K011905

DateFirm and productCodeLinked 510(k)
Jan 13, 2010Cordis Corporation
Cordis Aquatrack Hydrophilic Nitinol Guidewire, for use in angiographic procedures, REF C3526-SSA, Guidewire Diameter .035" Tip Length Flexible 3 cm, Sterile. Contents 5 Hydrophilic guidewires and to
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087301, .035/150cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Arg
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087302, .035/180cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Arg
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087303, .035/300 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Ar
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087304, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argo
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087305, .035/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argo
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087306, .035/300 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argo
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087308, .035/180 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argo
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087309, .035/300 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argo
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087311, .035/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087312, .035/300 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argon
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087313, .038/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Ar
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087314, .038/180 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Ar
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087315, .038/300 cm, regular/straight/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Ar
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087316, .038/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argo
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087317, .038/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argo
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG087326, .032/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in bulk non-sterile packaging. Argo
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387301, .035/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medic
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387302, .035/180 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medic
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387303, .035/300 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medic
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387304, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387305, .035/180 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387306, .035/300 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387307, .035/150 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387308, .035/180 cm, still/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387309, .035/300 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387310, .035/150 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical D
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387311, .035/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical D
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387312, .035/300 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical D
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387313, .038/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medic
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387314, .038/180 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medic
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387316, .038/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387318, .038/300 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387319, .038/150 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387320, .038/180 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387321, .038/300 cm, stiff/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387322, .038/150 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical D
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387323, .038/180 cm, stiff/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical D
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387325, .032/150 cm, regular/straight/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medic
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, Catalog Number: AG387326, .032/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Argon Medical
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Hydrophilic Guidewire, Catalog Number: TVS3010, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. Total Vein Solutions, 901 Yale Street - Houston, Tex
Terminated
DQXNone listed
May 26, 2009Argon Medical Devices, Inc
Hydrophilic Guidewire, Catalog Number: VM18352, .035/150 cm, regular/angled/standard, sold as a single hydrophilic guidewire in sterile packaging. VisioMed International Group Inc., 14555 South Robe
Terminated
DQXNone listed
Jan 31, 2008Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG087312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk no
Terminated
DQXNone listed
Jan 31, 2008Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387307, .035/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk
Terminated
DQXNone listed
Jan 31, 2008Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387308, .035/180cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk
Terminated
DQXNone listed
Jan 31, 2008Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387309, .035/300cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk
Terminated
DQXNone listed
Jan 31, 2008Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387310, .035/150cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk no
Terminated
DQXNone listed
Jan 31, 2008Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387311, .035/180cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk no
Terminated
DQXNone listed
Jan 31, 2008Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387312, .035/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk no
Terminated
DQXNone listed
Jan 31, 2008Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387319, .038/150cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk
Terminated
DQXNone listed
Jan 31, 2008Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387320, .038/180cm, stiff/straight/standard, sold as a single hydrophilic guidewire in both sterile and bulk
Terminated
DQXNone listed
Jan 31, 2008Argon Medical Devices, Inc
Argon Medical Devices, ArgoGuide Hydrophilic NiTi Guidewire, K011905, Catalog Number: 00-AG387324, .038/300cm, stiff/angled/standard, sold as a single hydrophilic guidewire in both sterile and bulk no
Terminated
DQXNone listed

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