Definition: To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy
| Device Type ID | 962 |
| Device Name | Catheter For Crossing Total Occlusions |
| Physical State | Peripheral Catheter |
| Technical Method | Creates Narrow Channel In Occlusion To Allow For Guidewire Placement For Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement. |
| Target Area | Peripheral Vasculature |
| Regulation Description | Percutaneous Catheter. |
| 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 | 870.1250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PDU |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 962 |
| Device | Catheter For Crossing Total Occlusions |
| Product Code | PDU |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous Catheter. |
| CFR Regulation Number | 870.1250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
AVINGER, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORP. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BOSTON SCIENTIFIC CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORDIS CORP., A JOHNSON & JOHNSON CO. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORDIS CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
CORDIS CORPORATION, A JOHNSON & JOHNSON COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
RA MEDICAL SYSTEMS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Material Separation | 141 |
Detachment Of Device Or Device Component | 66 |
Fracture | 50 |
Device-Device Incompatibility | 46 |
Catheter | 43 |
Retraction Problem | 42 |
Needle | 29 |
Material Twisted / Bent | 26 |
Torn Material | 25 |
Device Inoperable | 20 |
Break | 17 |
Tip | 14 |
Adverse Event Without Identified Device Or Use Problem | 12 |
Failure To Advance | 12 |
Material Deformation | 11 |
Difficult To Remove | 10 |
Overheating Of Device | 9 |
Kinked | 8 |
Material Puncture / Hole | 8 |
Bent | 6 |
Difficult Or Delayed Activation | 6 |
Noise, Audible | 6 |
Leak / Splash | 5 |
Unraveled Material | 5 |
Connection Problem | 4 |
Extrusion | 4 |
Difficult Or Delayed Positioning | 4 |
Activation Problem | 4 |
Device Contamination With Chemical Or Other Material | 4 |
Detachment Of Device Component | 3 |
Hole In Material | 3 |
Stretched | 3 |
Difficult To Advance | 3 |
Indicator | 3 |
Entrapment Of Device | 3 |
Device Dislodged Or Dislocated | 3 |
Use Of Device Problem | 2 |
Structural Problem | 2 |
Activation, Positioning Or Separation Problem | 2 |
Material Frayed | 2 |
Cannula | 2 |
Shaft | 2 |
Material Integrity Problem | 2 |
Device Operates Differently Than Expected | 1 |
Delivered As Unsterile Product | 1 |
Loss Of Or Failure To Bond | 1 |
Device Abrasion From Instrument Or Another Object | 1 |
No Apparent Adverse Event | 1 |
Material Split, Cut Or Torn | 1 |
Device Alarm System | 1 |
Positioning Problem | 1 |
Filter | 1 |
Packaging Problem | 1 |
Difficult To Position | 1 |
Crack | 1 |
Unsealed Device Packaging | 1 |
Device Damaged By Another Device | 1 |
Mechanical Jam | 1 |
Unintended Movement | 1 |
Cannula Guide | 1 |
Poor Quality Image | 1 |
Peeled / Delaminated | 1 |
| Total Device Problems | 691 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Volcano Corporation | II | Sep-02-2015 |