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)
Jul 19, 2022Cook 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
DQXK182985
Jul 19, 2022Cook 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
DQXK182985
Nov 3, 2020Cook 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
DQXNone listed
May 7, 2020Argon Medical Devices, Inc
0.035"(.89mm)x150 cm guidewire. Model 114135150. Soft Tip 3.5cm. REF/UDI: 114135150/(01)20886333008074. RxOnly.STERILE EO
Terminated
DQXK160785
May 7, 2020Argon Medical Devices, Inc
0.035"(.89mm)x80 cm guidewire. Model 114135080. Soft Tip 3.5cm. REF/UDI: 114135080/(01)208863333008067. RxOnly STERILE EO
Terminated
DQXK160785
Dec 12, 2019Arrow 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
DQXK810675
Oct 29, 2019Stryker 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
DQXK190843
Oct 29, 2019Stryker 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
DQXK190843
Oct 29, 2019Stryker 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
DQXK190843
Oct 29, 2019Stryker 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
DQXK190843
Oct 29, 2019Stryker 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
DQXK190843
Oct 29, 2019Stryker 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
DQXK190843
Oct 29, 2019Stryker 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
DQXK190843
Oct 29, 2019Stryker 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
DQXK190843
May 23, 2019Anewmed Corporation
Various products which were contract sterilized.
Open, Classified
DQXNone listed
Dec 19, 2018Boston 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
DQXK122795
Apr 11, 2018Arrow International Inc
Arterial Catheterization Kit; Product Code:NA-04550-1A
Terminated
DQXK810675
Apr 11, 2018Arrow International Inc
Radial Artery Catheterization Kit with Sharps Safety Features; Product Codes: ASK-04020-RIHM
Terminated
DQXK810675
Apr 11, 2018Arrow International Inc
Arterial Catheterization Kit; Product Codes: ASK-04020-DH
Terminated
DQXK810675
Apr 11, 2018Arrow International Inc
Radial Artery Catheterization Kit; Product Codes: ASK-04020-AH, ASK-04020-MIHS, ASK-04120-HF1
Terminated
DQXK810675
Apr 11, 2018Arrow International Inc
Arterial Line Kit with Sharps Safety Features and Maximal Barrier Precautions; Product Code: ASK-04018-OH1
Terminated
DQXK810675
Apr 11, 2018Arrow International Inc
Radial Arterial Access Kit; Product Code: ASK-04001-BID2
Terminated
DQXK810675
Dec 22, 2017Arrow 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
DQXK810675
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04220
Terminated
DQXK810675
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04122
Terminated
DQXK810675
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04120
Terminated
DQXK810675
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04020-C
Terminated
DQXK810675
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04020
Terminated
DQXK810675
Oct 26, 2017Arrow International Inc
Radial Artery Catheterization Kit; Model: AK-04018
Terminated
DQXK810675
Oct 13, 2017Cook Inc.
TFE Coated Curved Newton LLT
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Rosen Curved Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Reuter Tip Deflecting Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Newton Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Movable Core Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Fixed Core Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Fixed Core Bentson
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Double Flexible Tipped Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Disposable Reuter Tip Deflecting Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Coons Interventional Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Bentson Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Bentson Plus Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Bentson Cerebral Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Amplatz Ultra Stiff Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Amplatz Stiff Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Amplatz Extra Stiff Wire Guide
Terminated
DQXNone listed
Oct 13, 2017Cook Inc.
Amplatz Extra Stiff Whisker Wire Guide
Terminated
DQXNone listed
May 9, 2017Arrow 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
DQXK810675
Nov 9, 2016SentreHeart 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
DQXK080364
Nov 9, 2016Micro 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
DQXNone listed
Sep 7, 2016Arrow 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
DQXK810675

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