ClearanceBrief
Panels › Cardiovascular › Product code DQX · Class 2

Wire, Guide, Catheter

Regulation 870.1330

12510(k)s in 12 months (769 all time)
7recalls in 12 months (258 all time)
224recalls that name a 510(k)
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Top companies in DQX

DateFirm and productCodeLinked 510(k)
Jan 7, 2011Boston Scientific Corporation
Boston Scientific brand Synchro.14" Guide Wire, 45 cm, tip; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corpor
Terminated
DQXK050964
Jan 7, 2011Boston Scientific Corporation
Boston Scientific brand Synchro.14" Guide Wire, 35 cm, tip; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific Corpor
Terminated
DQXK050964
Jan 7, 2011Boston Scientific Corporation
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard Pre-Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Bost
Terminated
DQXK053268
Jan 7, 2011Boston Scientific Corporation
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Standard; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientif
Terminated
DQXK053268
Jan 7, 2011Boston Scientific Corporation
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard Pre-Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Bost
Terminated
DQXK053268
Jan 7, 2011Boston Scientific Corporation
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Standard; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientif
Terminated
DQXK053268
Jan 7, 2011Boston Scientific Corporation
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft Pre Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston S
Terminated
DQXK053268
Jan 7, 2011Boston Scientific Corporation
Boston Scientific brand Synchro2 0.14" Guide Wire, 300 cm, Soft; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston Scientific C
Terminated
DQXK053268
Jan 7, 2011Boston Scientific Corporation
Boston Scientific brand Synchro2 0.14" Guide Wire, 200 cm, Soft Pre Shaped; Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119 Product is distributed by Boston S
Terminated
DQXK053268
Jan 7, 2011Boston Scientific Corporation
Boston Scientific brand Synchro 2 Guidewire, 0.14" 200 cm Soft. Boston Scientific; Made in: 2405 West Orton Circle, West Valley City, UT 84119 The Synchro guidewire series is intended for general in
Terminated
DQXK053268
Sep 25, 2010Arrow International Inc
Femoral Artery Catheterization Set
Terminated
DQXK810675
Sep 25, 2010Arrow International Inc
Arterial Catheterization Set
Terminated
DQXK810675
Jul 22, 2010Boston Scientific Corporation
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 300 cm x 10 cm, REF 50-815, UPN M001508150 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle
Terminated
DQXK053268
Jul 22, 2010Boston Scientific Corporation
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 300 cm x 10 cm, REF 50-814, UPN M001508140 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Vall
Terminated
DQXK053268
Jul 22, 2010Boston Scientific Corporation
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, Pre-Shaped 200 cm x 10 cm, REF 50-811, UPN M001508110 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle
Terminated
DQXK053268
Jul 22, 2010Boston Scientific Corporation
Boston Scientific, Fathom"-14 Steerable Guidewire, Peripheral Vascular Use, 200 cm x 10 cm, REF 50-810, UPN M001508100 Sterilized with ethylene oxide gas, Rx Only, Made in 2405 Orion Circle, West Vall
Terminated
DQXK053268
Jun 28, 2010Merit Medical Systems, Inc.
Merit Laureate Hydrophylic Guide Wire, Straight Stiff Shaft, Made in Ireland, CAT No: LWSTFS35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the
Terminated
DQXK092303
Jun 28, 2010Merit Medical Systems, Inc.
Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the p
Terminated
DQXK092303
Jun 28, 2010Merit Medical Systems, Inc.
Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35260EX, 260cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of
Terminated
DQXK092303
Jun 28, 2010Merit Medical Systems, Inc.
Merit Laureate Hydrophylic Guide Wire, Straight, Made In Ireland, CAT No: LWSTFS35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of
Terminated
DQXK092303
Jun 28, 2010Merit Medical Systems, Inc.
Merit Laureate Hydrophylic Guide Wire, Angled Stiff Shaft, Made In Ireland, CAT No: LWSTFA35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the pla
Terminated
DQXK092303
Jun 28, 2010Merit Medical Systems, Inc.
Merit Laureate Hydrophylic Guide Wire, Angled, Made In Ireland, CAT No: LWSTDA35180, 180cm, Sterile EO, Merit Medical Systems, Inc., South Jordan, UT 84095. Intended to facilitate the placement of de
Terminated
DQXK092303
Jun 4, 2010Boston Scientific Corporation
Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide. The steerable guidewires are made of a stainless-steel, PTFE-coated proximal shaft, which tapers down to a ver
Terminated
DQXK011906
K020283
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
DQXK011905
Sep 18, 2009St. Jude Medical
St. Jude Medical FAST-CATH Hemostasis Introducer 4F, REF 406709, Length 12 CM, Lot 4219 Max. Guidewire O.D. .038", 2010-01, Manufacture, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-21
Terminated
DQXK791129
Sep 18, 2009St. Jude Medical
St. Jude Medical FAST-CATH Hemostasis Introducer 7F, REF 406702, Length 12 CM, Lot 6372 Max. Guidewire O.D. .038", 2010-01, Manufacturer, St. Jude Medical, 14901 DeVeau place, Minnetonka, MN 55345-2
Terminated
DQXK791129
Aug 17, 2009St. Jude Medical
SJM Peel Away Introducer, REF 405153, Lot 2694252, Length 14 cm, 7F (2.33 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN
Terminated
DQXK791129
Aug 17, 2009St. Jude Medical
SJM Peel Away Introducer, REF 405116, Lot 2694227, Length 14 cm, 9F (3.00 mm), Max Guidewire o.d .038" (.965 mm), contents 5, 2011-08, Manufacturer St Jude Medical 14901 DeVeau Place, Minnetonka, MN
Terminated
DQXK791129
Jun 24, 2009Boston Scientific Corporation
Boston Scientific, Fort Guide Wire, Floppy, 300cm x 2 cm REF 34949-04, for use in intravascular interventional procedures.
Terminated
DQXK011968
Jun 24, 2009Boston Scientific Corporation
Boston Scientific Fort Guide Wire, Floppy Marker Wire, 300cm x 2 cm, REF 34949-02, for use in intravascular interventional procedures.
Terminated
DQXK011968
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905
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
DQXK011905

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