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

Company	510(k)s	Recalls
Cook Incorporated	26	61
Boston Scientific	34	42
Argon Medical Devices, Inc.	1	53
Asahi Intecc Co., Ltd.	48	0
Advanced Cardiovascular Systems, Inc.	45	0
Arrow International, Inc.	1	31
Lake Region Mfg., Inc.	31	0
Merit Medical Systems, Inc.	22	9
Scimed Life Systems, Inc.	30	0
Guidant Corp.	27	0

Date	Firm and product	Code	Linked 510(k)
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
May 26, 2009	Argon 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	DQX	K011905
Oct 2, 2008	Boston Scientific Corporation Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01 Terminated	DQX	K935997 K945379
Oct 2, 2008	Boston Scientific Corporation Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxide gas, Rx only, Legal Manufacturer Boston Scientific Corporation, One Boston scientific Place, Natick, MA 01 Terminated	DQX	K935997 K945379
Sep 21, 2008	Boston Scientific Corporation Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Catalog # 1754, Material No. [Inner Pouch Label] H74917540. Sterilized with ethylene oxide gas. The Platinum Terminated	DQX	K935997
Sep 21, 2008	Boston Scientific Corporation Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531, Catalog # 1753, Material No. [Inner Pouch Label] H74917530. Sterilized with ethylene oxide gas. The Platinum Terminated	DQX	K935997
Sep 21, 2008	Boston Scientific Corporation Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917521, Catalog # 1752, Material No. [Inner Pouch Label] H74917520. Sterilized with ethylene oxide gas. The Platinum Terminated	DQX	K935997
Sep 21, 2008	Boston Scientific Corporation Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917511, Catalog # 1751, Material No. [Inner Pouch Label] H74917510. Sterilized with ethylene oxide gas. The Platinum Terminated	DQX	K935997
Sep 16, 2008	Medical Components, Inc dba MedComp CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other in Terminated	DQX	K031916
Feb 6, 2008	Cook, Inc. THSCF-35-260-3-AUS2, (Cook Vascular Wire Guide, PTFE coated curved Amplatz ultra stiff catheter exchange, Diameter .035 Inch, length 260 cm, curve radius 3 mm, Cook Incorporated, Bloomington, IN 474 Terminated	DQX	K832178
Jan 31, 2008	Argon 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	DQX	K011905
Jan 31, 2008	Argon 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	DQX	K011905
Jan 31, 2008	Argon 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	DQX	K011905
Jan 31, 2008	Argon 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	DQX	K011905
Jan 31, 2008	Argon 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	DQX	K011905
Jan 31, 2008	Argon 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	DQX	K011905
Jan 31, 2008	Argon 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	DQX	K011905
Jan 31, 2008	Argon 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	DQX	K011905
Jan 31, 2008	Argon 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	DQX	K011905
Jan 31, 2008	Argon 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	DQX	K011905
Dec 5, 2007	Boston Scientific Target Boston Scientific Target, Transend EX Soft Tip Guide Wire, .014in /205cm, UPN: M001468060, Catalog Number: 46-806, Boston Scientific Target, Fremont, CA 94538 Terminated	DQX	K931584
Mar 21, 2007	Boston Scientific Boston Scientific Medi-Tech(R) Katzen (TM) Infusion Wire, for the infusion of therapeutic agents (i.e. heparin, saline, thrombolytic agents, etc.) in the peripheral vasculature. The wire allows for t Terminated	DQX	K883880
Sep 29, 2006	Micrus Endovascular Corporation Micrus brand WATUSI Guidewire 0.014'' - Soft Tip, Catalog Number; WST 140205-00; Distributed by Micrus Endovascular Corporation. San Jose, CA Terminated	DQX	K053265
Sep 29, 2006	Boston Scientific Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires ar Terminated	DQX	K030617
Sep 29, 2006	Boston Scientific Boston Scientific PT2 Moderate Support Guide Wire 185cm J-Tip, Catalog Number 38931-03 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires ar Terminated	DQX	K030617
Sep 29, 2006	Boston Scientific Boston Scientific PT2 Light Support Guide Wire 300cm J-Tip, Catalog Number 38931-02 . Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are Terminated	DQX	K030617
Sep 29, 2006	Boston Scientific Boston Scientific PT2 Light Support Guide Wire 185cm J-Tip, Catalog Number 38931-01. Sold in single pack and 5-pack. PTCA Guide Wire with Hydrophilic Coating. Boston Scientific Guide Wires are Terminated	DQX	K030617
Jul 12, 2006	Boston Scientific Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-01J0, 185 cm, J-Tip, Single Pack. Catalog No. 38951-01J2, 185 cm, J-Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corpora Terminated	DQX	None listed
Jul 12, 2006	Boston Scientific Boston Scientific IQ Guide Marker Wire. Catalog No. 38951-010, 185 cm, Straight Tip, Single Pack. Catalog No. 38951-012, 185 cm, Straight Tip, 5 pack. Sterile EO. Manufactured for: Boston Scient Terminated	DQX	None listed
Jul 12, 2006	Boston Scientific Boston Scientific IQ Guide Wire. Catalog No. 38950-02J0, 300 cm, J-Tip, Single Pack. Catalog No. 38950-02J2, 300 cm, J-Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Corporation, O Terminated	DQX	None listed
Jul 12, 2006	Boston Scientific Boston Scientific IQ Guide Wire. Catalog No. 38950-020, 300 cm, Straight Tip, Single Pack. Catalog No. 38950-022, 300 cm, Straight Tip, 5 pack. Sterile EO. Manufactured for: Boston Scientific Co Terminated	DQX	None listed

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