Definition: The Device Is Intended To Restore Blood Flow By Removing Thrombus/clots In Patients Experiencing Ischemic Stroke. The Prior Clearances In This Category Have Been Limited To Simply Identifying Catheter Placed In The Peripheral, Coronary, And Neurovasc
| Device Type ID | 3631 |
| Device Name | Catheter, Thrombus Retriever |
| Regulation Description | Percutaneous Catheter. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Neurology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Neurological And Physical Medicine Devices (DNPMD) Neurointerventional Devices Branch (NIDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.1250 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NRY |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 3631 |
| Device | Catheter, Thrombus Retriever |
| Product Code | NRY |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Percutaneous Catheter. |
| CFR Regulation Number | 870.1250 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
CONCENTRIC MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
INNEUROCO, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR | ||
SUBSTANTIALLY EQUIVALENT | 8 | |
MICROVENTION, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
PENUMBRA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 11 | |
STRYKER | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 6 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 605 |
Break | 309 |
Device Damaged Prior To Use | 264 |
Out-Of-Box Failure | 200 |
Kinked | 191 |
Physical Resistance | 137 |
Fracture | 118 |
Material Deformation | 76 |
Stretched | 65 |
Failure To Advance | 62 |
Difficult To Remove | 54 |
Physical Resistance / Sticking | 51 |
Retraction Problem | 40 |
Device Handling Problem | 33 |
Material Separation | 32 |
Aspiration Issue | 32 |
Device Operates Differently Than Expected | 27 |
Unraveled Material | 24 |
Difficult To Advance | 17 |
Mechanical Problem | 16 |
Entrapment Of Device | 15 |
Collapse | 14 |
Deformation Due To Compressive Stress | 14 |
Detachment Of Device Or Device Component | 12 |
Mechanical Jam | 11 |
Crack | 10 |
Suction Problem | 10 |
Bent | 10 |
Material Integrity Problem | 10 |
Misconnection | 9 |
Device Operational Issue | 7 |
Detachment Of Device Component | 7 |
Fluid Leak | 6 |
Pumping Stopped | 6 |
Decrease In Suction | 6 |
Leak / Splash | 5 |
Patient-Device Incompatibility | 5 |
Material Twisted / Bent | 4 |
Device Contamination With Body Fluid | 4 |
Catheter | 4 |
No Apparent Adverse Event | 4 |
Occlusion Within Device | 4 |
Defective Device | 4 |
Improper Flow Or Infusion | 4 |
Insufficient Information | 4 |
Noise, Audible | 4 |
Flaked | 3 |
No Pressure | 3 |
Hole In Material | 3 |
Device Emits Odor | 3 |
Failure To Power Up | 3 |
Obstruction Of Flow | 3 |
Shipping Damage Or Problem | 2 |
Tip | 2 |
Material Puncture / Hole | 2 |
Connection Problem | 2 |
Backflow | 2 |
Material Frayed | 2 |
Defective Component | 2 |
Power Problem | 2 |
Migration Or Expulsion Of Device | 2 |
Material Fragmentation | 2 |
Air Leak | 2 |
Device Packaging Compromised | 2 |
Peeled / Delaminated | 2 |
Sticking | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Difficult To Insert | 2 |
Loose Or Intermittent Connection | 2 |
Split | 2 |
Overheating Of Device | 2 |
Difficult To Position | 1 |
Cut In Material | 1 |
Device Or Device Fragments Location Unknown | 1 |
Difficult To Open Or Remove Packaging Material | 1 |
Premature Separation | 1 |
Device-Device Incompatibility | 1 |
Decrease In Pressure | 1 |
Knotted | 1 |
Pumping Problem | 1 |
Separation Failure | 1 |
Folded | 1 |
Device Damaged By Another Device | 1 |
Positioning Failure | 1 |
Off-Label Use | 1 |
Human-Device Interface Problem | 1 |
Suction Failure | 1 |
None | 1 |
Electrical /Electronic Property Problem | 1 |
Chemical Problem | 1 |
Activation Failure Including Expansion Failures | 1 |
Appropriate Term/Code Not Available | 1 |
Material Split, Cut Or Torn | 1 |
No Flow | 1 |
Physical Property Issue | 1 |
Therapeutic Or Diagnostic Output Failure | 1 |
Use Of Device Problem | 1 |
Stent | 1 |
Difficult To Flush | 1 |
Failure To Pump | 1 |
| Total Device Problems | 2631 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Concentric Medical Inc | II | Dec-08-2014 |
| 2 | Concentric Medical Inc | II | Sep-08-2014 |
| 3 | Micro Therapeutics Inc, Dba Ev3 Neurovascular | I | May-16-2018 |
| 4 | Penumbra Inc. | I | Jun-22-2017 |
| 5 | Stryker Neurovascular | II | Jan-14-2018 |
| 6 | Stryker Neurovascular | II | Dec-05-2017 |
| 7 | Stryker Neurovascular | II | Jul-29-2017 |