| Device Type ID | 740 |
| Device Name | Wire, Guide, Catheter |
| Regulation Description | Catheter Guide Wire. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Peripheral Interventional Devices Branch (PIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1330 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DQX |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 740 |
| Device | Wire, Guide, Catheter |
| Product Code | DQX |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Catheter Guide Wire. |
| CFR Regulation Number | 870.1330 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
ACCELLENT INC | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
ARGON MEDICAL DEVICES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARGON MEDICAL DEVICES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ASAHI | ||
SUBSTANTIALLY EQUIVALENT | 10 | |
ASAHI INTECC CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 10 | |
ASHITAKA FACTORY OF TERUMO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 9 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
BOSTON SCIENTIFIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BRIVANT, LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONCERT MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 11 | |
DISTAL ACCESS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HERAEUS MEDICAL COMPONENTS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LAKE REGION MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 7 | |
NANO4IMAGING GMBH | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
NEEDLETECH PRODUCTS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
NEOMETRICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ST. JUDE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STEREOTAXIS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
TERUMO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VADISWIRE CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VASCULAR SOLUTIONS, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VASCULAR SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
VOLCANO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILLIAM COOK | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WILLIAM COOK EUROPE APS | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Break | 588 |
Detachment Of Device Component | 571 |
Guidewire | 571 |
Peeled / Delaminated | 458 |
Difficult To Remove | 383 |
Material Separation | 380 |
Entrapment Of Device | 373 |
Adverse Event Without Identified Device Or Use Problem | 371 |
Tip | 364 |
Fracture | 357 |
Detachment Of Device Or Device Component | 198 |
Material Deformation | 151 |
Kinked | 145 |
Stretched | 144 |
Material Integrity Problem | 142 |
Unraveled Material | 110 |
Difficult To Advance | 102 |
Flaked | 97 |
Device Damaged By Another Device | 85 |
Failure To Advance | 82 |
Material Fragmentation | 77 |
Physical Resistance | 76 |
Improper Or Incorrect Procedure Or Method | 69 |
Bent | 55 |
Insufficient Information | 53 |
Device Damaged Prior To Use | 46 |
Deformation Due To Compressive Stress | 46 |
Device Operates Differently Than Expected | 45 |
Occlusion Within Device | 44 |
Positioning Problem | 40 |
Difficult To Position | 35 |
Wire | 32 |
Delamination | 28 |
Device Contamination With Chemical Or Other Material | 28 |
Material Protrusion / Extrusion | 26 |
Material Frayed | 26 |
Uncoiled | 24 |
Product Quality Problem | 24 |
Material Twisted / Bent | 23 |
Catheter | 23 |
Leak / Splash | 22 |
Material Split, Cut Or Torn | 20 |
Appropriate Term/Code Not Available | 16 |
Fluid Leak | 16 |
Split | 15 |
Torn Material | 15 |
Sticking | 15 |
Material Distortion | 13 |
Difficult To Insert | 13 |
Off-Label Use | 12 |
Device Misassembled During Manufacturing / Shipping | 11 |
Partial Blockage | 11 |
Use Of Device Problem | 11 |
Device Markings / Labelling Problem | 10 |
Filter | 10 |
Collapse | 10 |
Crack | 10 |
Mechanical Problem | 9 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 9 |
Unable To Obtain Readings | 9 |
Physical Resistance / Sticking | 9 |
Material Torqued | 8 |
Cut In Material | 8 |
Material Too Soft / Flexible | 8 |
Physical Property Issue | 8 |
Obstruction Of Flow | 7 |
Activation, Positioning Or Separation Problem | 7 |
Retraction Problem | 7 |
Device Or Device Fragments Location Unknown | 7 |
Unsealed Device Packaging | 7 |
Wire(s), Breakage Of | 6 |
Device Issue | 6 |
Device Displays Incorrect Message | 6 |
Human-Device Interface Problem | 6 |
Tip Breakage | 5 |
Device Dislodged Or Dislocated | 5 |
Defective Device | 5 |
Core | 5 |
Scratched Material | 4 |
Malposition Of Device | 4 |
Material Perforation | 4 |
Packaging Problem | 4 |
Hole In Material | 4 |
Material Too Rigid Or Stiff | 4 |
Contamination / Decontamination Problem | 4 |
Contamination During Use | 4 |
Patient-Device Incompatibility | 4 |
Migration Or Expulsion Of Device | 3 |
Coiled | 3 |
Difficult Or Delayed Positioning | 3 |
No Flow | 3 |
Material Puncture / Hole | 3 |
Device Abrasion From Instrument Or Another Object | 3 |
Seal | 3 |
Device Packaging Compromised | 3 |
Component Or Accessory Incompatibility | 3 |
No Device Output | 3 |
Device Slipped | 2 |
Failure To Align | 2 |
Device Disinfection Or Sterilization Issue | 2 |
| Total Device Problems | 6941 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arrow International Inc | II | May-30-2018 |
| 2 | Arrow International Inc | II | Apr-10-2018 |
| 3 | Arrow International Inc | II | Apr-02-2018 |
| 4 | Arrow International Inc | II | Jun-12-2017 |
| 5 | Arrow International Inc | II | Sep-07-2016 |
| 6 | Arrow International Inc | II | Jul-12-2016 |
| 7 | Baylis Medical Corp * | II | Dec-01-2015 |
| 8 | Baylis Medical Corp * | II | Apr-13-2015 |
| 9 | Boston Scientific Corporation | II | Feb-20-2019 |
| 10 | Boston Scientific Corporation | II | Apr-12-2016 |
| 11 | Cook Inc. | II | Mar-09-2018 |
| 12 | Cook Inc. | I | Aug-25-2016 |
| 13 | EXP Pharmaceutical Services Corp | II | Jul-24-2015 |
| 14 | Merit Medical Systems, Inc. | II | Jun-26-2015 |
| 15 | Merit Medical Systems, Inc. | II | Apr-22-2014 |
| 16 | Micro Therapeutics Inc, Dba Ev3 Neurovascular | I | Nov-09-2016 |
| 17 | Nitinol Devices And Components, Inc. | I | Jun-25-2014 |
| 18 | SentreHeart Inc | I | Nov-09-2016 |
| 19 | Volcano Corporation | II | Jun-25-2015 |