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)
Top companies in DQX
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 19, 2022 | Cook Incorporated Roadrunner PC Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): RFSPC-35-180
ORDER NUMBER (GPN) G09608. For vascular catheter positioning and exchange in diagnostic and interventional procedures. Open, Classified |
DQX | K182985 |
| Jul 19, 2022 | Cook Incorporated Roadrunner PC Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN)RFPC-35-180
ORDER NUMBER (GPN) G07937. For vascular catheter positioning and exchange in diagnostic and interventional procedures. Open, Classified |
DQX | K182985 |
| Nov 3, 2020 | Cook Inc. Fixed Core Wire Guide, RPN TSCF-35-260-3, GPN G00517. The product is a curved wire guide with PTFE coating manufactured from stainless steel. To assist in inserting catheters, introducer sheaths, and Terminated |
DQX | None listed |
| May 7, 2020 | Argon Medical Devices, Inc 0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO Terminated |
DQX | K160785 |
| May 7, 2020 | Argon Medical Devices, Inc 0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO Terminated |
DQX | K160785 |
| Dec 12, 2019 | Arrow International Inc Arrow Arterial Catherization Kit-20 Ga. x 4.45 cm Radiopaque Polyurethane over 22 Ga. TW Introducer Needle with Integral .018" (0.46 mm) dia. Spring-Wire Guide
Product Code: ASK-04020-PMC
The Arrow Open, Classified |
DQX | K810675 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 300cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326520, REF 2652, STERILE: EO - Product Usage: product is intended for general intravascular use, i Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 300cm STANDARD Guidewire with Hydrophilic Coating UPN Product No. M00326510, REF 2651, STERILE:EO - Product Usage: product is intended for general intravascular use, including neur Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in. x 200cm STANDARD PRE-SHAPED Guidewire with Hydrophilic Coating UPN Product No. M00326420, REF 2642, STERILE: EO - Product Usage: product is intended for general intravascular use, i Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 200cm STANDARD Guidewire with Hydrophilic Coating, UPN Product No. M00326410, REF 2641, STERILE: EO - Product Usage: product is intended for general intravascular use, including ne Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in. x 300cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326320, REF 2632, STERILE:EO - Product Usage: product is intended for general intravascular use, incl Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 300cm SOFT Guidewire with Hydrophilic Coating , UPN Product No. M00326310, REF 2631, STERILE:EO - Product Usage: product is intended for general intravascular use, including neurov Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014in x 200cm, SOFT PRE-SHAPED Guidewire with Hydrophilic Coating, UPN Product No. M00326110, REF 2611, STERILE: EO - Product Usage: product is intended for general intravascular use, inc Terminated |
DQX | K190843 |
| Oct 29, 2019 | Stryker Neurovascular Synchro2, 0.014 in x 200cm, SOFT Guidewire with Hydrophilic Coating, UPN Product No. M00326010 REF 2601, STERILE: EO - Product Usage: product is intended for general intravascular use, including neuro Terminated |
DQX | K190843 |
| May 23, 2019 | Anewmed Corporation Various products which were contract sterilized. Open, Classified |
DQX | None listed |
| Dec 19, 2018 | Boston Scientific Corporation Stingray" Guidewire, labeled as 300cm. intended to facilitate placement of balloon dilatation catheters or other intravascular devices during percutaneous transluminal coronary angioplasty (PTCA) and Terminated |
DQX | K122795 |
| Apr 11, 2018 | Arrow International Inc Arterial Catheterization Kit; Product Code:NA-04550-1A Terminated |
DQX | K810675 |
| Apr 11, 2018 | Arrow International Inc Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM Terminated |
DQX | K810675 |
| Apr 11, 2018 | Arrow International Inc Arterial Catheterization Kit; Product Codes: ASK-04020-DH Terminated |
DQX | K810675 |
| Apr 11, 2018 | Arrow International Inc Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1 Terminated |
DQX | K810675 |
| Apr 11, 2018 | Arrow International Inc Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1 Terminated |
DQX | K810675 |
| Apr 11, 2018 | Arrow International Inc Radial Arterial Access Kit; Product Code: ASK-04001-BID2 Terminated |
DQX | K810675 |
| Dec 22, 2017 | Arrow International Inc (1) Arterial Catheterization Kit, Part Number (PN): ASK-04018-CC; (2) Arterial Line Kit with Sharps Safety Features, PN: ASK-04510-HUM; (3) Arterial Line Kit with Sharps Safety Features, PN: ASK-04550 Terminated |
DQX | K810675 |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04220 Terminated |
DQX | K810675 |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04122 Terminated |
DQX | K810675 |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04120 Terminated |
DQX | K810675 |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04020-C Terminated |
DQX | K810675 |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04020 Terminated |
DQX | K810675 |
| Oct 26, 2017 | Arrow International Inc Radial Artery Catheterization Kit; Model: AK-04018 Terminated |
DQX | K810675 |
| Oct 13, 2017 | Cook Inc. TFE Coated Curved Newton LLT Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Rosen Curved Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Reuter Tip Deflecting Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Newton Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Movable Core Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Fixed Core Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Fixed Core Bentson Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Double Flexible Tipped Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Disposable Reuter Tip Deflecting Wire
Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Coons Interventional Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Bentson Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Bentson Plus Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Bentson Cerebral Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Amplatz Ultra Stiff Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Amplatz Stiff Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Amplatz Extra Stiff Wire Guide Terminated |
DQX | None listed |
| Oct 13, 2017 | Cook Inc. Amplatz Extra Stiff Whisker Wire Guide Terminated |
DQX | None listed |
| May 9, 2017 | Arrow International Inc Arterial Catheterization Kit,
Arterial Line Kit with Sharps Safety Features
wire, guide, catheter
The Arrow Arterial Catheterization device permits access to the peripheral arterial circulation or Terminated |
DQX | K810675 |
| Nov 9, 2016 | SentreHeart Inc FindrWIRZ Guidewire System Catalog# 40-05
Cardiology:
The system is intended for use in the cardiovascular system for
introduction and positioning of over the-wire catheters and therapeutic devices d Terminated |
DQX | K080364 |
| Nov 9, 2016 | Micro Therapeutics Inc, Dba Ev3 Neurovascular X-Celerator Hydrophilic Exchange Guidewire
Catalog No.
103-0601-300
103-0601-350V10
103-0602-350V06
103-0601-300V01
103-0602-300
103-0602-350V09
103-0601-300V02
103-0602-300V01
103-0602-350V10
103-06 Terminated |
DQX | None listed |
| Sep 7, 2016 | Arrow International Inc Radial Artery Catheterization Kit with Sharps Safety Features
Permits access to the peripheral arterial circulation. The safety feature is intended to help minimize the risk of sharps injuries when us Terminated |
DQX | K810675 |
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