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) |
|---|---|---|---|
| Sep 7, 2016 | Arrow International Inc Arterial Line Catheterization Kit with Sharps Safety Features
Permits access to the peripheral arterial circulation or to other small vessels. Terminated |
DQX | K810675 |
| Aug 25, 2016 | Cook Inc. Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-3 Terminated |
DQX | K110009 K130766 |
| Jul 12, 2016 | Arrow International Inc Femoral Arterial Line
Catheterization Kit with Sharps Safety Features
510K 810675, product code DQX, Device Listing D025180
Material ASK-04018-VUH
Product Usage:
The Arrow arterial catheterization de Terminated |
DQX | K810675 |
| Jul 12, 2016 | Arrow International Inc Femoral Arterial Line
Catheterization Kit with Sharps Safety Features
510K 810675, product code DQX, Device Listing D025180
Material ASK-04018-VUH
Product Usage:
The Arrow arterial catheterization de Terminated |
DQX | K810675 |
| Mar 28, 2016 | Boston Scientific Corporation Boston Scientific, PT Graphix Magnet J-TIP Guidewire
with ICE Hydrophilic Coating, Sterile EO, UPN H7491490201MJ2 (Carton Label) ,H7491490201MJo (UPN referenced on the Pouch Label) .
Boston Scientifi Terminated |
DQX | K143587 |
| Dec 1, 2015 | Baylis Medical Corp * ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coa Terminated |
DQX | K014075 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange PT WIRE 300;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 38931-04;
EXP (repackager), Boston Scientific (OEM)
Wire, guide, catheter Terminated |
DQX | None listed |
| Jun 25, 2015 | Volcano Corporation Prestige Plus 185cm J-Tip:
Part number: 9185J;
Product Usage: The Prestige Plus Wire is indicated for use to measure pressure in blood vessels including both coronary and peripheral vessels, during Terminated |
DQX | K111395 |
| Apr 13, 2015 | Baylis Medical Corp * ProTrack Microcatheter;
Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Terminated |
DQX | K014075 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Stiff Shaft, Straight Tip, 260 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: Terminated |
DQX | K121398 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire;
0.035 OD, Stiff Shaft, Straight Tip, 180 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: NDC Inc., Fremont, CA.
The HydroFinity Hydrophilic gu Terminated |
DQX | K121398 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Stiff Shaft, Straight Tip, 150 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: Terminated |
DQX | K121398 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Stiff Shaft, Angled Tip, 260 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: NDC Terminated |
DQX | K121398 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire;Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Stiff Shaft, Angled Tip, 180 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: NDC Terminated |
DQX | K121398 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Stiff Shaft, Angled Tip, 150 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: ND Terminated |
DQX | K121398 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Straight Tip, 260 CM Length
Manufactured for Covidien, Plymouth, MN;
Manufactured by Terminated |
DQX | K121398 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Straight Tip, 180 CM Length;
Ma Terminated |
DQX | K121398 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Straight Tip, 150 CM Length
Manufactured for Covidien, Plymouth, MN;
Manufactured by Terminated |
DQX | K121398 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Angled Tip, 260 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: Terminated |
DQX | K121398 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Angled Tip, 180 CM Length;
Manufactured for Covidien, Plymouth, MN;
Manufactured by: Terminated |
DQX | K121398 |
| Jun 25, 2014 | Nitinol Devices and Components, Inc. HydroFinity Hydrophilic guidewire; Nitinol Guidewire with Hydrophilic Coating, Sterile.
0.035 OD, Standard Shaft, Angled Tip, 150 CM Length
Manufactured for Covidien, Plymouth, MN;
Manufactured by: Terminated |
DQX | K121398 |
| Apr 22, 2014 | Merit Medical Systems, Inc. Merit Laureate 0.035" (0.89mm) Hydrophilic Guide Wire, Angled Tip, Standard Shaft, Catalog No. LWSTDA35260EX, 260 cm (102"). Terminated |
DQX | K120644 |
| Apr 22, 2014 | Merit Medical Systems, Inc. Merit Laureate Hydrophilic Guide Wire, Catalog No. LWSTFS35260EX, Straight Tip Stiff Shaft, 0.035" (0.89mm), 260 cm (102"). Terminated |
DQX | K120644 |
| Dec 20, 2013 | Abbott Vascular, Inc. HT Connect Peripheral Guide Wire
Part Number Description
1012587 018 HT CONNECT 145 CM
1012588 018 HT CONNECT 195 CM
1012589 018 HT CONNECT 300 CM
1012590 018 HT Terminated |
DQX | None listed |
| Nov 15, 2013 | Medtronic Vascular COUGAR Steerable Guidewire; Models: LVCLS190J, LVCLS190S, LVCXT190J, LVCXT190S
Medtronic guide wires are steerable guide wires that are used for the introduction and placement of diagnostics or inter Terminated |
DQX | K032899 |
| Nov 15, 2013 | Medtronic Vascular ATTAIN HYBRID Guide Wire; Models: GWR419478, GWR419488, GWR419688
The Attain Hybrid guide wire is intended to aid in the placement of Medtronic transvenous left ventricular leads in the coronary vasc Terminated |
DQX | K063210 |
| Nov 15, 2013 | Medtronic Vascular ProVia CROSSING GUIDEWIRE; Models: 15PROV300HS, 3PROV180HS, 3PROV180SS, 3PROV300HS, 3PROV300SS, 9PROV180HS, 9PROV180SS
Medtronic guide wires are steerable guide wires that are used for the introduct Terminated |
DQX | K091582 K100470 |
| Nov 15, 2013 | Medtronic Vascular Cougar Nitinol Workhorse Guidewire: Models: CGRLS190HJ, CGRLS190HS, CGRLS190S, CGRLS300HS, CGRLS300S. CGRXT190HJ, CGRXT190HS, CGRXT190J, CGRXT190S, CGRXT300HJ, CGRXT300HS, CGRXT300J, CGRXT300S
Medtr Terminated |
DQX | K032899 |
| Mar 28, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Archer 0.035 inch (0.89mm) Super Stiff Guidewire, Models ARCSJ200W, ARCSJ260W, and ARCDJ260W. Sterile using ethylene oxide.
Product Usage:
The Medtronic Archer 0.035 inch (0.89mm) Super Terminated |
DQX | K101339 |
| Mar 28, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Archer Super Stiff Guidewire 0.035 inch (0.89mm), Model ARCSJ200W.
Intended to facilitate catheter placement and exchange during procedures in the aorta. Terminated |
DQX | K101339 |
| Oct 25, 2012 | Nipro Medical Corporation AquaLiner Hydrophilic Guidewire 0.035" X 180cm, Angle / Regular.
AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional dev Terminated |
DQX | K001251 |
| Oct 25, 2012 | Nipro Medical Corporation AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Stiff.
AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional dev Terminated |
DQX | K001251 |
| Oct 25, 2012 | Nipro Medical Corporation AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Straight/ Regular.
AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional d Terminated |
DQX | K001251 |
| Oct 25, 2012 | Nipro Medical Corporation AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Stiff.
AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional device Terminated |
DQX | K001251 |
| Oct 25, 2012 | Nipro Medical Corporation AquaLiner Hydrophilic Guidewire 0.035" X 260cm, Angle/ Regular.
AquaLiner Hydrophilic Guidewire is designed for use in angiographic procedures to introduce/ position catheters and interventional devi Terminated |
DQX | K001251 |
| Feb 1, 2012 | Volcano Corporation FloWire Doppler Guide wires.
Volcano Corporation,
Rancho Cardova, Ca.
The Volcano FloWire Doppler guide wire is a single use guide wire intended for use in all blood vessels including both coronary Terminated |
DQX | K972762 |
| Aug 23, 2011 | Boston Scientific Corporation Katzen" Infusion Wire, 0.035 in x 180 cm,
UPN Product No. M001461930,
RED Catalog No. 46-193,
Made in USA 8600.
Boston Scientific.
NW 41 Street, Miami, FL 33166.
Intended for the infusion of the Terminated |
DQX | K883880 |
| Jul 20, 2011 | Terumo Medical Corporation Runthrough NS Tapered PTCA Guidewire, item code number TW*DP418FH
Product Usage The Runthrough NS guidewire is used to facilitate placement of balloon dilation catheters for Percutaneous Translumina Terminated |
DQX | K063695 |
| Jul 12, 2011 | Abbott Vascular Abbott Vascular ACS .035 Torque Device
Part Number : 1003279.
For use in cardiac diagnostic or therapeutic procedures. Terminated |
DQX | K950752 |
| Feb 17, 2011 | Arrow International Inc ARTERIAL ACCESS TRAY/Product SKU (Code) MMC-04001-1.
Arterial access tray for radial artery catheterization set Terminated |
DQX | K810675 |
| Feb 17, 2011 | Arrow International Inc RADIAL ARTERY CATHETERIZATION KIT with SHARPS SAFETY FEATURES/Product SKU (Code) HF-04020-1.
Cardiovascular catheter wire guide Terminated |
DQX | K810675 |
| Feb 17, 2011 | Arrow International Inc ARTERIAL CATHETERIZATION KIT/Product SKU's (Codes) CC-04100, FS-04510, NS-04100 and PW-04100.
Cardiovascular catheterization kit Terminated |
DQX | K810675 |
| Feb 17, 2011 | Arrow International Inc QuickFlash(R) RADIAL ARTERY/ARTERIAL LINE CATHETERIZATION KIT/Product SKU (Code) ASK-04500-HF.
Radial artery catheterization kit Terminated |
DQX | K810675 |
| Feb 17, 2011 | Arrow International Inc RADIAL ARTERY CATHETERIZATION KIT/Product SKU (Code) ASK-04120-VBH.
Cardiovascular artery catheterization kit Terminated |
DQX | K810675 |
| Feb 17, 2011 | Arrow International Inc ARTERIAL CATHETERIZATION KIT/Product SKU (Code) ASK-04100-AMC.
Arterial catheterization kit Terminated |
DQX | K810675 |
| Feb 17, 2011 | Arrow International Inc ARTERIAL LINE KIT/Product SKU (Code) AK-04510
Arterial line kit Terminated |
DQX | K810675 |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Sci Terminated |
DQX | K050964 |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro.14" Guide Wire, 200 cm length, 35 cm tip;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Sci Terminated |
DQX | K050964 |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 45 cm tip;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Sci Terminated |
DQX | K050964 |
| Jan 7, 2011 | Boston Scientific Corporation Boston Scientific brand Synchro.14" Guide Wire, 300 cm length, 35 cm tip;
Boston Scientific Corporation: Made in 2405 West Orton Circle, West Valley City, UT 84119
Product is distributed by Boston Sci Terminated |
DQX | K050964 |
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