|
Device |
wire, guide, catheter |
Product Code | DQX |
Regulation Number |
870.1330
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
ABBOTT VASCULAR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ABBOTT VASCULAR-CARDIAC THERAPIES |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ACME-MONACO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARGON MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASAHI INTECC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
27
|
ASAHI INTECC CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASAHI INTECC USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASHITAKA FACTORY OF TERUMO COPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASHITAKA FACTORY OF TERUMO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAYLIS MEDICAL COMPANY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BEIJING BYWAVE SENSING MEDICAL TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOMERICS NLE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
9
|
BOSTON SCIENTIFIC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRIDGEPOINT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BRIVANT LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRIVANT LIMITED (LAKE REGION MEDICAL) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BRIVANT, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
CARDIO FLOW, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIOSOLUTIONS INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CENTURION MEDICAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CODMAN & SHURTLEFF, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COEUR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONCERT MEDICAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
12
|
COOK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
COVIDIEN LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DISTAL ACCESS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ELCAM MEDICAL A.C.A.L. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMBRACE MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FILMEC CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FILMECC CO. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FILMECC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FILMECC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FLAT MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FMD CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GUIDEPATH MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HERAEUS MEDICAL COMPONENTS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LAKE REGION MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
10
|
LAKE REGION MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LAKE REGION MFG., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDCOMP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIVALVE LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC CORE VALVE, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC COREVALVE, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MENNEN MEDICAL LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEM, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
14
|
MICRO THERAPEUTICS, INC D/B/A: EV3 INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO THERAPEUTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICROVENTION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MICRUS ENDOVASCULAR CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NANO4IMAGING GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NAVIS MEDICAL,INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEEDLETECH PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEO METRICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NEOMETRICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPSENS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OPSENS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
OPSENS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
OSCOR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHENOX LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIENTIA CARDIO ACCESS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIENTIA VASCULAR LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SEVEN SONS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHEPHERD SCIENTIFIC INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPARTAN MICRO, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST. JUDE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STEREOTAXIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUREFIRE MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUZHOU INNOMED MEDICAL DEVICE CO.,LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TATARA VASCULAR, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECHDEVICE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K110241 ENDOLOGIX GUIDEWIRE
|
TERUMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TEXAS MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VADISWIRE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASCULAR SOLUTIONS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASCULAR SOLUTIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VASCULAR SOLUTIONS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASCULAR SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
VESATEK, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VOLCANO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
WILLIAM COOK EUROPE APS |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
Patient Problems |
MDRs with this Patient Problem |
Events in those MDRs |
No Consequences Or Impact To Patient |
4992 |
4992 |
No Clinical Signs, Symptoms or Conditions |
3654 |
4752 |
Foreign Body In Patient |
1649 |
1649 |
Device Embedded In Tissue or Plaque |
1496 |
1496 |
No Known Impact Or Consequence To Patient |
1302 |
1790 |
No Patient Involvement |
545 |
545 |
Vascular Dissection |
516 |
638 |
Insufficient Information |
384 |
384 |
Perforation of Vessels |
384 |
506 |
Perforation |
311 |
311 |
Vessel Or Plaque, Device Embedded In |
296 |
296 |
Death |
279 |
279 |
Pericardial Effusion |
212 |
212 |
Cardiac Tamponade |
203 |
203 |
No Code Available |
198 |
198 |
Cardiac Perforation |
190 |
190 |
Low Blood Pressure/ Hypotension |
190 |
190 |
No Information |
175 |
175 |
Intimal Dissection |
131 |
131 |
Hemorrhage/Bleeding |
121 |
121 |
Myocardial Infarction |
111 |
111 |
Hematoma |
76 |
76 |
Stroke/CVA |
74 |
74 |
Obstruction/Occlusion |
70 |
70 |
Cardiac Arrest |
66 |
66 |
Pain |
62 |
62 |
Patient Problem/Medical Problem |
55 |
55 |
Blood Loss |
54 |
54 |
Occlusion |
54 |
54 |
Thrombosis |
51 |
51 |
Embolism |
50 |
50 |
Vasoconstriction |
49 |
49 |
Rupture |
42 |
42 |
Hemoptysis |
39 |
39 |
Intracranial Hemorrhage |
34 |
34 |
Embolism/Embolus |
31 |
31 |
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available |
31 |
31 |
Thrombosis/Thrombus |
30 |
30 |
Chest Pain |
29 |
29 |
Injury |
28 |
28 |
Bradycardia |
27 |
27 |
Hemorrhage, Subarachnoid |
26 |
26 |
Headache |
26 |
26 |
Laceration(s) |
25 |
25 |
Arrhythmia |
25 |
25 |
Angina |
24 |
24 |
Thrombus |
24 |
24 |
Tissue Damage |
22 |
22 |
Cardiogenic Shock |
20 |
20 |
Calcium Deposits/Calcification |
20 |
20 |
Unspecified Infection |
19 |
19 |
Ischemia |
18 |
18 |
Stenosis |
18 |
18 |
High Blood Pressure/ Hypertension |
17 |
17 |
Unspecified Tissue Injury |
17 |
17 |
Hemorrhage, Cerebral |
16 |
16 |
Aneurysm |
16 |
16 |
Tachycardia |
16 |
16 |
Extravasation |
15 |
15 |
Embolus |
14 |
14 |
Ventricular Fibrillation |
14 |
14 |
Discomfort |
13 |
13 |
Inflammation |
13 |
13 |
Aortic Dissection |
13 |
13 |
Pseudoaneurysm |
12 |
12 |
Foreign Body Embolism |
12 |
12 |
Non specific EKG/ECG Changes |
12 |
12 |
Atrial Fibrillation |
12 |
12 |
Needle Stick/Puncture |
11 |
11 |
Respiratory Failure |
10 |
10 |
Complete Heart Block |
10 |
10 |
Failure of Implant |
9 |
9 |
Dyspnea |
9 |
9 |
Nonresorbable materials, unretrieved in body |
9 |
9 |
Foreign body, removal of |
9 |
9 |
Internal Organ Perforation |
9 |
9 |
Transient Ischemic Attack |
9 |
9 |
ST Segment Elevation |
9 |
9 |
Neurological Deficit/Dysfunction |
8 |
8 |
Paralysis |
8 |
8 |
Pleural Effusion |
8 |
8 |
Ventricular Tachycardia |
8 |
8 |
Great Vessel Perforation |
8 |
8 |
Cardiopulmonary Arrest |
8 |
8 |
Infarction, Cerebral |
8 |
8 |
Diminished Pulse Pressure |
8 |
8 |
Swelling/ Edema |
7 |
7 |
Bone Fracture(s) |
7 |
7 |
Mitral Regurgitation |
7 |
7 |
Swelling |
7 |
7 |
Sepsis |
7 |
7 |
Pneumothorax |
6 |
6 |
Fistula |
6 |
6 |
Air Embolism |
6 |
6 |
Vascular System (Circulation), Impaired |
6 |
6 |
Not Applicable |
6 |
6 |
Mitral Valve Insufficiency/ Regurgitation |
5 |
5 |
Loss Of Pulse |
5 |
5 |
Surgical procedure, additional |
5 |
5 |
Atrial Perforation |
5 |
5 |
|
|
|
|