| Device Type ID | 736 |
| Device Name | Catheter, Intravascular, Diagnostic |
| Regulation Description | Diagnostic Intravascular Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1200 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DQO |
| 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 | 736 |
| Device | Catheter, Intravascular, Diagnostic |
| Product Code | DQO |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Diagnostic Intravascular Catheter. |
| CFR Regulation Number | 870.1200 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ANGIODYNAMICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ASHITAKA FACTORY OF TERUMO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ASHITAKA FACTORY OF TERUMO CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SUBSTANTIALLY EQUIVALENT | 10 | |
LIGHTLAB IMAGING, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDLINE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDLINE INDUSTRIES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC VASCULAR | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SCIENTIA VASCULAR , LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUREFIRE MEDICAL, INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SUREFIRE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
TERUMO CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
VASCULAR SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Filter | 921 |
Adverse Event Without Identified Device Or Use Problem | 589 |
Catheter | 459 |
Failure To Align | 398 |
Device Contamination With Chemical Or Other Material | 353 |
Fracture | 351 |
Material Separation | 283 |
Retraction Problem | 231 |
Difficult To Remove | 165 |
Unintended Movement | 139 |
Detachment Of Device Component | 132 |
Delivered As Unsterile Product | 125 |
Occlusion Within Device | 77 |
Tear, Rip Or Hole In Device Packaging | 74 |
Crack | 64 |
Shaft | 57 |
Break | 54 |
Detachment Of Device Or Device Component | 44 |
Tip | 44 |
Packaging Problem | 40 |
Unsealed Device Packaging | 39 |
Device Packaging Compromised | 37 |
Air Leak | 34 |
Leak / Splash | 32 |
Entrapment Of Device | 30 |
Seal | 25 |
Hub | 24 |
Material Puncture / Hole | 20 |
Tip Breakage | 19 |
Migration Or Expulsion Of Device | 17 |
Kinked | 17 |
Material Fragmentation | 17 |
Device Operates Differently Than Expected | 13 |
Partial Blockage | 12 |
Torn Material | 12 |
Insufficient Information | 11 |
Difficult To Advance | 10 |
Hole In Material | 10 |
Indicator | 9 |
Fluid Leak | 9 |
Burst Container Or Vessel | 9 |
Structural Problem | 8 |
Split | 8 |
Material Rupture | 8 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 7 |
Component(s), Broken | 7 |
Device Issue | 7 |
Device-Device Incompatibility | 7 |
Material Integrity Problem | 7 |
Migration | 7 |
Obstruction Of Flow | 6 |
Stent | 6 |
Unable To Obtain Readings | 6 |
Failure To Adhere Or Bond | 5 |
Bent | 5 |
Infusion Or Flow Problem | 4 |
Material Twisted / Bent | 4 |
Defective Component | 4 |
Appropriate Term/Code Not Available | 4 |
Material Frayed | 4 |
Device Damaged Prior To Use | 4 |
Flaked | 4 |
Positioning Failure | 4 |
Expulsion | 3 |
Device Contaminated During Manufacture Or Shipping | 3 |
Material Deformation | 3 |
Therapy Delivered To Incorrect Body Area | 3 |
Difficult To Insert | 3 |
Material Perforation | 3 |
Component Misassembled | 3 |
Connection Problem | 3 |
Balloon | 3 |
Unraveled Material | 3 |
Material Split, Cut Or Torn | 3 |
Luer Valve | 3 |
Deflation Problem | 3 |
Delamination | 3 |
Activation, Positioning Or Separation Problem | 3 |
Device Operational Issue | 3 |
Problem With Sterilization | 3 |
Physical Resistance | 3 |
Absorber | 2 |
Failure To Advance | 2 |
Deformation Due To Compressive Stress | 2 |
Shipping Damage Or Problem | 2 |
Cannula, Inner | 2 |
Inaccurate Dispensing | 2 |
Defective Device | 2 |
Stretched | 2 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 2 |
Peeled / Delaminated | 2 |
Device Damaged By Another Device | 2 |
Material Too Rigid Or Stiff | 1 |
Misassembly By Users | 1 |
Physical Resistance / Sticking | 1 |
No Pressure | 1 |
Inadequacy Of Device Shape And/or Size | 1 |
Fitting Problem | 1 |
Aspiration Issue | 1 |
Misplacement | 1 |
| Total Device Problems | 5216 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Angiodynamics, Inc. | II | Feb-13-2018 |
| 2 | Arrow International Inc | II | Nov-02-2016 |
| 3 | B. Braun Medical, Inc. | II | May-20-2016 |
| 4 | Boston Scientific Corporation | II | Jun-27-2017 |
| 5 | Boston Scientific Corporation | II | Mar-23-2017 |
| 6 | Cook Inc. | II | Aug-22-2016 |
| 7 | Cook Inc. | I | Feb-24-2016 |
| 8 | Cook Inc. | I | Aug-05-2015 |
| 9 | LeMaitre Vascular, Inc. | II | Mar-13-2017 |
| 10 | Medtronic Vascular | III | Sep-26-2018 |
| 11 | Medtronic Vascular | II | Apr-20-2018 |
| 12 | Numed Inc | II | Nov-28-2018 |
| 13 | Stryker Sustainability Solutions | I | Jul-22-2016 |
| 14 | Vascular Solutions, Inc. | II | Feb-23-2017 |
| 15 | Vascular Solutions, Inc. | I | Oct-20-2016 |
| 16 | Vascular Solutions, Inc. | I | Jul-03-2014 |
| 17 | Volcano Corporation | II | Sep-12-2014 |