|
Device |
catheter, thrombus retriever |
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 neurovasculature. It is felt that this is a unique claim and should not be combined with previously cleared catheters under a general procode. |
Product Code | NRY |
Regulation Number |
870.1250
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ALEMBIC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CERENOVUS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CODMAN & SHURTLEFF, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMPERATIVE CARE INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
INNEUROCO INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNEUROCO, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
INNEUROCO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MICRO THERAPEUTICS, INC., D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROVENTION INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROVENTION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEURAVI LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NEURAVI, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PENUMBRA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
16
|
1. K152541 Penumbra System ACE 64 and ACE 68 Reperfusion Cath ...
|
2. K160449 Penumbra System, Penumbra Pump MAX
|
3. K161064 Penumbra System ACE 68 Reperfusion Catheter
|
4. K161640 Penumbra System ACE 68 Reperfusion Catheter
|
5. K162901 Penumbra 3D Revascularization Device
|
6. K173761 Penumbra System Reperfusion Catheter JET 7
|
7. K180008 Penumbra System
|
8. K182522 Penumbra System (Modified 110 Aspiration Tubing)
|
9. K190010 Penumbra System Reperfusion Catheter JET 7
|
10. K190464 Penumbra System 3D Revascularization Device
|
11. K191946 Penumbra System Penumbra JET 7X
|
12. K202251 Penumbra System (Penumbra JET 7 Reperfusion Cathet ...
|
13. K203440 Penumbra System (Reperfusion Catheter RED 62)
|
14. K211411 Penumbra System (RED 68 Reperfusion Catheter)
|
15. K211654 Penumbra System (Reperfusion Catheter RED 72)
|
16. K222808 Penumbra System (Reperfusion Catheter RED 43)
|
PERFUZE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
Q'APEL MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RAPID MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ROUTE 92 MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SCIENTIA VASCULAR INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
STRYKER NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
WALLABY MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Patient Problems |
MDRs with this Patient Problem |
Events in those MDRs |
No Consequences Or Impact To Patient |
1210 |
1210 |
No Clinical Signs, Symptoms or Conditions |
1005 |
1005 |
Intracranial Hemorrhage |
680 |
680 |
No Patient Involvement |
336 |
336 |
Thromboembolism |
199 |
199 |
Death |
183 |
183 |
Vasoconstriction |
180 |
180 |
Vascular Dissection |
174 |
174 |
Perforation of Vessels |
165 |
165 |
Hemorrhage/Bleeding |
159 |
159 |
Foreign Body In Patient |
155 |
155 |
Stroke/CVA |
145 |
145 |
No Known Impact Or Consequence To Patient |
134 |
134 |
Hemorrhage, Subarachnoid |
123 |
123 |
Device Embedded In Tissue or Plaque |
108 |
108 |
Insufficient Information |
93 |
93 |
Ischemia Stroke |
92 |
92 |
Obstruction/Occlusion |
85 |
85 |
Embolism/Embolus |
85 |
85 |
Unspecified Nervous System Problem |
82 |
82 |
Hemorrhage, Cerebral |
82 |
82 |
Hematoma |
81 |
81 |
Neurological Deficit/Dysfunction |
72 |
72 |
Infarction, Cerebral |
71 |
71 |
Swelling/ Edema |
61 |
61 |
Embolus |
56 |
56 |
Thrombosis/Thrombus |
47 |
47 |
Stenosis |
37 |
37 |
Perforation |
35 |
35 |
Extravasation |
32 |
32 |
Therapeutic Response, Decreased |
30 |
30 |
Rupture |
28 |
28 |
Edema |
27 |
27 |
Ischemia |
27 |
27 |
Pseudoaneurysm |
26 |
26 |
Hemorrhagic Stroke |
23 |
23 |
Fistula |
23 |
23 |
Cerebral Edema |
22 |
22 |
Occlusion |
21 |
21 |
Paralysis |
19 |
19 |
No Code Available |
18 |
18 |
Muscle Weakness |
15 |
15 |
Respiratory Failure |
14 |
14 |
Cognitive Changes |
13 |
13 |
Headache |
13 |
13 |
Intimal Dissection |
13 |
13 |
Paresis |
12 |
12 |
Thrombosis |
12 |
12 |
Dysphasia |
12 |
12 |
Embolism |
11 |
11 |
Coma |
10 |
10 |
Heart Failure/Congestive Heart Failure |
10 |
10 |
Patient Problem/Medical Problem |
9 |
9 |
Hydrocephalus |
9 |
9 |
Convulsion/Seizure |
9 |
9 |
Thrombus |
8 |
8 |
Low Blood Pressure/ Hypotension |
8 |
8 |
Unspecified Infection |
8 |
8 |
Hemorrhage, Intraventricular |
7 |
7 |
High Blood Pressure/ Hypertension |
7 |
7 |
Necrosis |
7 |
7 |
Fever |
7 |
7 |
Aspiration/Inhalation |
7 |
7 |
Visual Impairment |
7 |
7 |
Sepsis |
6 |
6 |
Atrial Fibrillation |
6 |
6 |
Anemia |
6 |
6 |
Bradycardia |
6 |
6 |
Failure of Implant |
6 |
6 |
Pain |
6 |
6 |
Inflammation |
6 |
6 |
Vessel Or Plaque, Device Embedded In |
5 |
5 |
Foreign Body Reaction |
5 |
5 |
Visual Disturbances |
5 |
5 |
Ventilator Dependent |
5 |
5 |
Speech Disorder |
5 |
5 |
No Information |
5 |
5 |
Injury |
4 |
4 |
Weakness |
4 |
4 |
Brain Injury |
4 |
4 |
Transient Ischemic Attack |
4 |
4 |
Death, Intrauterine Fetal |
4 |
4 |
Pulmonary Embolism |
4 |
4 |
Seizures |
4 |
4 |
Pneumonia |
4 |
4 |
Restenosis |
4 |
4 |
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available |
3 |
3 |
Respiratory Insufficiency |
3 |
3 |
Renal Failure |
3 |
3 |
Reocclusion |
3 |
3 |
Hypersensitivity/Allergic reaction |
3 |
3 |
Aneurysm |
3 |
3 |
Arrhythmia |
3 |
3 |
Cardiac Arrest |
3 |
3 |
Fatigue |
3 |
3 |
Hernia |
3 |
3 |
Numbness |
3 |
3 |
Loss of consciousness |
3 |
3 |
Nervous System Injury |
3 |
3 |
Blood Loss |
3 |
3 |
|
|
|
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