| Device Type ID | 832 |
| Device Name | Introducer, Catheter |
| Regulation Description | Catheter Introducer. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1340 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DYB |
| 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 | 832 |
| Device | Introducer, Catheter |
| Product Code | DYB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Catheter Introducer. |
| CFR Regulation Number | 870.1340 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ABBOTT LABORATORIES | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ACCESS SCIENTIFIC, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ALSEAL | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ANGIODYNAMICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ARGON MEDICAL DEVICES INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARGON MEDICAL DEVICES, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ARSTASIS | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
ARSTASIS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
BIOSENSE | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BIOSENSE WEBSTER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
C.R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
CARDIOSOLUTIONS INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CONTRACT MEDICAL INTL. GMBH | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
COOK, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SUBSTANTIALLY EQUIVALENT | 15 | |
CORDIS CORP. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CORDIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CREGANNA MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CREGANNA MEDICAL ALSO D/B/A CREGANNA-TACTX MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
EDWARDS LIFESCIENCES | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
EDWARDS LIFESCIENCES LLC | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
ENDOPHYS HOLDINGS, LLC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
ENDOPHYS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
EPIEP, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
GALT MEDICAL CORP. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SUBSTANTIALLY EQUIVALENT | 2 | |
GREATBATCH MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KALILA MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
LEPU MEDICAL TECHNOLOGY (BEJING) CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDCOMP (MEDICAL COMPONENTS, INC.) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC INC | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
MEDTRONIC VASCULAR | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC VASCULAR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDTRONIC, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
MERIT MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 2 | |
SUBSTANTIALLY EQUIVALENT | 8 | |
NUMED, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ONSET MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
OSCOR INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
OSCOR, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ST. JUDE MEDICAL (ABBOTT LABORATORIES) | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ST. JUDE MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
SYNAPTIC MEDICAL LIMITED | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
TERUMO CARDIOVASCULAR SYSTEMS | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
TERUMO MEDICAL CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
THERAGENICS CORP. | ||
SUBSTANTIALLY EQUIVALENT - KIT | 1 | |
SUBSTANTIALLY EQUIVALENT | 2 | |
VASCULAR SOLUTIONS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
W.L. GORE & ASSOCIATES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
W.L. GORE & ASSOCIATES,INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Separation | 840 |
Leak / Splash | 648 |
Adverse Event Without Identified Device Or Use Problem | 632 |
Break | 361 |
Valve | 349 |
Fluid Leak | 334 |
Detachment Of Device Component | 174 |
Detachment Of Device Or Device Component | 163 |
Fracture | 127 |
Difficult To Remove | 106 |
Material Deformation | 105 |
Unraveled Material | 101 |
Kinked | 90 |
Air Leak | 81 |
Material Frayed | 81 |
Difficult To Insert | 79 |
Catheter | 73 |
Torn Material | 59 |
Material Fragmentation | 59 |
Flaked | 57 |
Gas Leak | 56 |
Tip | 55 |
Material Split, Cut Or Torn | 49 |
Difficult To Advance | 49 |
Connection Problem | 46 |
Split | 44 |
Guidewire | 40 |
Use Of Device Problem | 36 |
Occlusion Within Device | 35 |
Failure To Advance | 35 |
Appropriate Term/Code Not Available | 34 |
Material Integrity Problem | 33 |
Hemo Valve | 32 |
Crack | 30 |
Device Contamination With Chemical Or Other Material | 29 |
Wire | 29 |
Physical Resistance | 29 |
Insufficient Information | 28 |
Device Operates Differently Than Expected | 27 |
Material Puncture / Hole | 24 |
Stretched | 24 |
Partial Blockage | 24 |
Device Damaged Prior To Use | 21 |
Bent | 21 |
Deformation Due To Compressive Stress | 20 |
Backflow | 20 |
Entrapment Of Device | 20 |
Patient-Device Incompatibility | 19 |
Hole In Material | 18 |
Positioning Problem | 17 |
Physical Resistance / Sticking | 15 |
Device Dislodged Or Dislocated | 14 |
Activation, Positioning Or Separation Problem | 13 |
Peeled / Delaminated | 13 |
Device Issue | 13 |
Hub | 13 |
Device Markings / Labelling Problem | 12 |
Positioning Failure | 12 |
Device-Device Incompatibility | 12 |
Component Missing | 12 |
Shaft | 12 |
Improper Or Incorrect Procedure Or Method | 11 |
Protective Measures Problem | 11 |
Material Perforation | 11 |
Difficult To Position | 11 |
Material Rupture | 10 |
Scratched Material | 10 |
Dull, Blunt | 10 |
Device Damaged By Another Device | 10 |
Fitting Problem | 10 |
Delamination | 10 |
Defective Component | 9 |
Tip Breakage | 9 |
Material Twisted / Bent | 9 |
Component(s), Broken | 9 |
Knotted | 8 |
Unsealed Device Packaging | 7 |
Disconnection | 7 |
Wrinkled | 7 |
Migration Or Expulsion Of Device | 7 |
Obstruction Of Flow | 7 |
Delivered As Unsterile Product | 6 |
Tear, Rip Or Hole In Device Packaging | 6 |
Mechanical Problem | 6 |
Other (for Use When An Appropriate Device Code Cannot Be Identified) | 6 |
Defective Device | 6 |
Device Packaging Compromised | 6 |
Material Too Rigid Or Stiff | 6 |
Patient Device Interaction Problem | 6 |
Device Handling Problem | 5 |
Wire(s), Breakage Of | 5 |
Inadequacy Of Device Shape And/or Size | 5 |
Device Or Device Fragments Location Unknown | 5 |
Packaging Problem | 5 |
Material Disintegration | 5 |
Uncoiled | 4 |
Human-Device Interface Problem | 4 |
Collapse | 4 |
Manufacturing, Packaging Or Shipping Problem | 4 |
Sticking | 4 |
| Total Device Problems | 5885 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Angiodynamics Inc. (Navilyst Medical Inc.) | II | Jun-14-2018 |
| 2 | Angiodynamics, Inc. | II | Dec-16-2016 |
| 3 | Angiodynamics, Inc. | III | Dec-16-2016 |
| 4 | Argon Medical Devices, Inc | II | Oct-07-2016 |
| 5 | Arrow International Inc | II | Jul-30-2018 |
| 6 | Arrow International Inc | II | May-30-2018 |
| 7 | Arrow International Inc | II | Apr-10-2018 |
| 8 | Arrow International Inc | II | Apr-02-2018 |
| 9 | Arrow International Inc | II | Mar-05-2018 |
| 10 | Arrow International Inc | II | Jun-27-2017 |
| 11 | Arrow International Inc | II | Jun-12-2017 |
| 12 | Arrow International Inc | II | Mar-07-2016 |
| 13 | Arrow International Inc | II | Jun-26-2015 |
| 14 | Arrow International Inc | II | Jun-04-2014 |
| 15 | BARD PERIPHERAL VASCULAR, INC | I | Jan-18-2017 |
| 16 | Biocardia, Inc. | II | Mar-27-2014 |
| 17 | Biocardia, Inc. | II | Feb-19-2014 |
| 18 | Boston Scientific Corporation | I | Dec-18-2015 |
| 19 | Cook Inc. | II | Feb-20-2019 |
| 20 | Cook Inc. | II | Mar-02-2017 |
| 21 | Cook Inc. | II | Aug-22-2016 |
| 22 | Cook Inc. | II | Feb-24-2016 |
| 23 | Cook Inc. | II | Jul-18-2015 |
| 24 | Creganna Medical Devices | II | Jun-14-2017 |
| 25 | Galt Medical Corporation | II | Jul-27-2018 |
| 26 | Galt Medical Corporation | II | Sep-04-2014 |
| 27 | Greatbatch Medical | II | Jul-29-2017 |
| 28 | Greatbatch Medical | II | Jul-29-2017 |
| 29 | Greatbatch Medical | II | Nov-18-2016 |
| 30 | Greatbatch Medical | II | May-13-2014 |
| 31 | Kalila Medical | II | Feb-09-2018 |
| 32 | Medical Components, Inc Dba MedComp | II | Jun-07-2016 |
| 33 | Medtronic Inc. Cardiac Rhythm Disease Management | I | Mar-17-2015 |
| 34 | Merit Medical Systems, Inc. | II | Feb-22-2018 |
| 35 | Merit Medical Systems, Inc. | I | Mar-24-2017 |
| 36 | Merit Medical Systems, Inc. | II | Jan-05-2017 |
| 37 | Oscor, Inc. | II | Dec-19-2016 |
| 38 | St Jude Medical | II | Oct-22-2014 |
| 39 | Sterilmed Inc | I | Dec-29-2017 |
| 40 | Stryker Instruments Div. Of Stryker Corporation | II | Dec-14-2015 |
| 41 | Terumo Medical Corp | II | Dec-08-2017 |
| 42 | Terumo Medical Corporation | II | Feb-26-2018 |
| 43 | Terumo Medical Corporation | II | May-04-2017 |
| 44 | Terumo Medical Corporation | II | Sep-06-2016 |