Panels › Cardiovascular › Product code DQX · Class 2
Wire, Guide, Catheter
Regulation 870.1330
13510(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) |
|---|---|---|---|
| Aug 7, 2026 | Galt Medical Corporation Boston Scientific Enhance Transcarotid/Peripheral Access Kit
REF: SR-4F21G7D-MP (Kit-075-03)
Sheath with Dilator , Stiffen Dilator, Nitinol Mandrel Wire w/ Radiopaque Tip [Au}, Needle, Extension Tube Open, Classified |
DQX | K000737 K021990 |
| Jun 18, 2026 | Merit Medical Systems, Inc. Splashwire Hydrophilic Guide Wire:
REF: MSWSTDA35150
UDI-DI codes:
00884450529645
00884450529669
00884450529690
REF: MSWSTDA35180
UDI-DI codes:
00884450529645
00884450529669
REF: MSWSTDA35260EX
UDI- Open, Classified |
DQX | K201595 |
| Jun 13, 2026 | ARROW INTERNATIONAL, LLC Description/REF:
RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-1A;
RA CATH KIT: 20 GA X 1-1/2IN/NA-04220-X1A;
ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018-HCA;
ARTERIAL CATHETER KIT: 18 GA X 16 CM/ASK-04018 Open, Classified |
DQX | K160018 K810675 |
| Apr 17, 2026 | Medline Industries, LP Medline Namic Guidewires:
1) GUIDEWIRE 3MMJ 0.035X260CM LT, Model Number: DYNJGWIRE20L;
2) GWIRE HYDRO 0.035 180CM ANG S, Model Number: DYNJHWIRE105;
3) GWIRE HYDRO 0.035 260CM ANG S, Model Number: Open, Classified |
DQX | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Approach CTO-18 Micro Wire Guide, Reference Part Number CMW-14-190-18G, Order Number G50788; Reference Part Number CMW-14-300-18G, Order Number G50792 Open, Classified |
DQX | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Approach CTO-12 Micro Wire Guide: Reference Part Number CMW-14-190-12G, Order Number G50787; Reference Part Number CMW-14-300-12G, Order Number G50791 Open, Classified |
DQX | None listed |
| Apr 6, 2026 | Cook Incorporated COOK MEDICAL Approach CTO-6 Micro Wire Guide, Reference Part Number CMW-14-190-6G, Order Number G50786 Open, Classified |
DQX | K171897 |
| May 7, 2025 | Galt Medical Corporation GALT Guidewire
REF SGW-051-07
Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral vascu Open, Classified |
DQX | K982559 |
| Nov 21, 2024 | Cook Incorporated Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789 Open, Classified |
DQX | K171897 |
| Nov 8, 2024 | Cook Incorporated Approach Hydro ST Micro Wire Guide; Catalog prefix HMW
Reference Part Numbers:
HMW-14-135-ST
HMW-14-190-ST
HMW-14-300-ST Open, Classified |
DQX | K091385 |
| Nov 8, 2024 | Cook Incorporated Approach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW;
Reference Part Numbers:
CMW-14-190-12G
CMW-14-190-18G
CMW-14-190-25G
CMW-14-190-6G
CMW-14-300-12G
CMW-14-300-18G
CMW-14-300-25G
CMW-14-3 Open, Classified |
DQX | K171897 |
| Sep 26, 2024 | ARROW INTERNATIONAL Inc. Arrow Arterial Kits and Trays as follows:
(1) Arrow Arterial Access Tray with 0.025" Spring-Wire Guide (Catheter Not Included), REF ASK-04001-BW1;
(2) Arrow Arterial Access Tray with 0.021" Spring- Open, Classified |
DQX | K810675 K914531 |
| Sep 6, 2024 | Bard Peripheral Vascular Inc Guidewire 70cm x 1mm (0.038 ) REF 5583705
These accessories are intended for use with Bard 14.5 Fr. Long-Term Dual Lumen
Hemodialysis Catheters. Please refer to the applicable catheter Instructions f Open, Classified |
DQX | K770977 |
| May 31, 2024 | Stryker Neurovascular The Synchro2 Guidewires are a steerable guidewire family with a shapeable tip and are available in straight and pre-shaped versions. The outside diameters of the guidewires are 0.014 in. The guidewire Open, Classified |
DQX | K053268 |
| May 31, 2024 | Stryker Neurovascular The Synchro Neuro Guidewires are a steerable guidewire family with a shapeable tip. The outside diameter of the Synchro 10 guidewire is 0.010in. The outside diameter of the Syncrho 14 guidewire is 0.0 Open, Classified |
DQX | K032146 |
| May 28, 2024 | Stryker Neurovascular Synchro .014"guide wire, 35 cm tip, Catalog: M00313010
Synchro .014 guide wire, 300 cm length, Catalog: M00313310
SYNCHRO .010 WIRE SOFT STRAIGHT 200cm, Catalog: M00316310
SYNCHRO .010 WIRE SOFT STRAI Open, Classified |
DQX | K002907 K023700 |
| Mar 21, 2024 | ARROW INTERNATIONAL Inc. ARROW QuickFlash Radial Artery Catherization (wire, guide, catheter), Part Numbers:
a) REF AK-04220;
b) REF ASK-04220-FMH1;
c) REF ASK-04220-HHC;
d) REF ASK-04220-KSP;
e) REF ASK-04220-PSU;
f) Open, Classified |
DQX | K160018 |
| Sep 28, 2022 | Cook Incorporated Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY)
Reference Part Number/GPN
TMT-35-145 G01677 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Movable Core Wire Guide (Tapered Tefcor) (OUS ONLY), Guidewire
Reference Part Number/GPN
TCMTNA-35-145-3 G01678 Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Lunderquist -Ring Torque Wire Guide, Guidewire
Reference Part Number/GPN
THSF-35-125-THG G27031
THSF-35-145-THG G27033 Open, Classified |
DQX | K171764 |
| Sep 28, 2022 | Cook Incorporated Torq-Flex Wire Guide Australian Modification, Guidewire
Reference Part Number/GPN
STF-18-40-AUST G07304 Open, Classified |
DQX | K171997 |
| Sep 28, 2022 | Cook Incorporated Rosen Curved Wire Guide, Guidewire
Reference Part Number/GPN
THSCF-35-220-1.5-ROSEN G01623
THSCF-35-80-1.5-ROSEN G01774
THSCF-35-180-1.5-ROSEN G01264
THSCF-35-145-1.5-ROSEN G01261 Open, Classified |
DQX | K171764 |
| Sep 28, 2022 | Cook Incorporated Roadrunner PC Wire Guide (The Firm), Guidewire
Reference Part Number/GPN
RPC-35-145 G06979
RPC-35-80 G09534 Open, Classified |
DQX | K182985 |
| Sep 28, 2022 | Cook Incorporated Roadrunner PC Wire Guide (The Firm LT), Guidewire
Reference Part Number/GPN
RLPC-35-145 G06866 Open, Classified |
DQX | K182985 |
| Sep 28, 2022 | Cook Incorporated Roadrunner PC Wire Guide (Nimble Floppy), Guidewire
RFPC-35-145 G07914 Open, Classified |
DQX | K182985 |
| Sep 28, 2022 | Cook Incorporated Roadrunner PC Wire Guide (Nimble), Guidewire
Reference Part Number/GPN:
RFSPC-35-145 G09607 Open, Classified |
DQX | K182985 |
| Sep 28, 2022 | Cook Incorporated Newton Wire Guide (LT Taper/10cm Distal Flexibility), Guidewire
Reference Part Number/GPN:
TSFNA-35-145 G00701
TSCFNA-35-145-3 G00561 Open, Classified |
DQX | K171764 |
| Sep 28, 2022 | Cook Incorporated Heavy Double Flexible Tipped Wire Guide, Guidewire
Reference Part Number/GPN:
THDOC-35-60-0-3 G11949
C-HDOC-18-40-0-2 G09201
C-THDOC-18-40-0-2-HTS G26925 Open, Classified |
DQX | K171912 |
| Sep 28, 2022 | Cook Incorporated Fixed Core Wire Guide (Straight), Guidewire
Reference Part Number/GPN:
C-SF-18-30 G02261
C-SF-25-40 G01937
TSF-18-260 G00590
C-SF-25-50 G01938
TSF-35-180 G00652
C-SF-18-40 G02255
TSF-25-145 G00617
TSF Open, Classified |
DQX | K171764 |
| Sep 28, 2022 | Cook Incorporated Fixed Core Wire Guide (Safe-T-J Curved), Guidewire
Reference Part Number/GPN:
TSCF-25-180-3 G01602
TSCF-35-180-3 G00902
TSCF-21-260-3 G00455
THSCF-25-260-3 G02384
TSCF-25-145-3 G00466
THSCF-35-80-3 G0 Open, Classified |
DQX | K171764 |
| Sep 28, 2022 | Cook Incorporated Fixed Core Wire Guide, Guidewire
Reference Part Number/GPN
THSCF-25-180-3 G02165
TSCF-25-80-3 G00476 Open, Classified |
DQX | K171764 |
| Sep 28, 2022 | Cook Incorporated Double Flexible Tipped Wire Guide, Guidewire
Reference Part Number/GPN
TDOC-35-145-0-3 G00362
C-TDOC-18-50-0-2 G05146
TDOC-35-50-0-3 G00364
C-DOC-21-40-0-2 G02431
C-TDOC-21-50-0-2 G05195
C-TDOC-25-50- Open, Classified |
DQX | K171912 K181351 |
| Sep 28, 2022 | Cook Incorporated Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire
Reference Part Number/GPN
PMG-18SP-60-COPE G05183
PMG-18SP-100-COPE G05822
PMG-18SP-125-COPE G10077 Open, Classified |
DQX | K171997 |
| Sep 28, 2022 | Cook Incorporated Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire;
Reference Part Number/GPN:
PMG-18SP-60-COPE-NT-ST G09395
PMG-18SP-100-COPE-NT G08687
PMG-18SP-60-COPE-NT G08427 Open, Classified |
DQX | K171997 |
| Sep 28, 2022 | Cook Incorporated Coons Interventional Wire Guide, Guidewire;
Reference Part Number/GPN:
THSF-35-145-COONS G02356
THSF-38-145-COONS G02324
THSF-35-180-COONS G02621
THSF-35-80-COONS G12268 Open, Classified |
DQX | K171764 |
| Sep 28, 2022 | Cook Incorporated Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire;
Reference Part Number:
TSFB-35-80 (GPN G01315)
TSFB-35-145 (GPN G00691)
TSFB-35-200 (GPN G01095) Open, Classified |
DQX | K171764 |
| Sep 28, 2022 | Cook Incorporated Bentson Wire Guide, Guidewire (OUS ONLY);
Reference Part Number:
TSMB-35-145 (GPN G27041) Open, Classified |
DQX | None listed |
| Sep 28, 2022 | Cook Incorporated Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire;
Reference Part Number:
TSFBP-35-180 (GPN G09782)
TSFBP-35-145 (GPN G09735) Open, Classified |
DQX | K171764 |
| Sep 28, 2022 | Cook Incorporated Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY);
Reference Part Number:
THSF-35-145-AES-SGH (GPN G06801)
THSF-38-80-AES-SGH (GPN G06874) Open, Classified |
DQX | None listed |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWS-35-80
ORDER NUMBER (GPN): G56151. For vascular catheter positioning and exchange in diagnostic and interventional proce Open, Classified |
DQX | K110009 |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWS-35-150
ORDER NUMBER (GPN): G56152. For vascular catheter positioning and exchange in diagnostic and interventional proc Open, Classified |
DQX | K110009 |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWAS-35-80
ORDER NUMBER (GPN): G56175. For vascular catheter positioning and exchange in diagnostic and interventional proce Open, Classified |
DQX | K110009 |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWAS-35-150
ORDER NUMBER (GPN): G56176. For vascular catheter positioning and exchange in diagnostic and interventional proc Open, Classified |
DQX | K110009 |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWA-35-80
ORDER NUMBER (GPN): G56172. For vascular catheter positioning and exchange in diagnostic and interventional proce Open, Classified |
DQX | K110009 |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWA-35-150
ORDER NUMBER (GPN): G56173. For vascular catheter positioning and exchange in diagnostic and interventional proc Open, Classified |
DQX | K110009 |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWA-18-80
ORDER NUMBER (GPN): G56162. For vascular catheter positioning and exchange in diagnostic and interventional proced Open, Classified |
DQX | K110009 |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPWA-18-150
ORDER NUMBER (GPN):G56161. For vascular catheter positioning and exchange in diagnostic and interventional proced Open, Classified |
DQX | K110009 |
| Jul 19, 2022 | Cook Incorporated Roadrunner UniGlide Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): HPW-35-150
ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedu Open, Classified |
DQX | K110009 |
| Jul 19, 2022 | Cook Incorporated Roadrunner PC Hydrophilic Wire Guide
REFERENCE PART NUMBER (RPN): RPC-35-180
ORDER NUMBER (GPN):G07518. 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):RLPC-35-180
ORDER NUMBER (GPN) G07516. For vascular catheter positioning and exchange in diagnostic and interventional procedures. Open, Classified |
DQX | K182985 |
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