|
Device |
catheter, intravascular, diagnostic |
Product Code | DQO |
Regulation Number |
870.1200
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ACCURATE MEDICAL THERAPEUTICS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACCURATE MEDICAL THERAPEUTICS LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACCURATE MEDICAL THERAPEUTICS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANGIODYNAMICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
ASHITAKA FACTORY OF TERUMO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ASHITAKA FACTORY OF TERUMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BEND IT TECHNOLOGIES LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSENSORS INTL. PTE. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOTEQUE CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K102633 BIOTEQ ANGIOGRAPHIC CATHETER
|
BOSTON SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COLIBRI TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONAVI MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONCENTRIC MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
|
SUBSTANTIALLY EQUIVALENT
|
9
|
COOK, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORDIS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORDIS US CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CORDIS, A CARDINAL HEALTH COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CURATIVE MEDICAL TECHNOLOGY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EDWARDS LIFESCIENCES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EMBOLX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GENTUITY, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
IMPERATIVE CARE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LIGHTLAB IMAGING, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDIGUIDE, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDLINE, INDUSTRIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC VASCULAR |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MICROVENTION, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRUS ENDOVASCULAR CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NAVILYST MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
OSCOR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PEDIACATH INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PFM MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHENOX LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SCIENTIA VASCULAR , LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SCIENTIA VASCULAR LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS MEDICAL SOLUTIONS USA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST. JUDE MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
STRYKER |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SUREFIRE MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
SUREFIRE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SUZHOU HENGRUI DISHENG MEDICAL CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO CLINICAL SUPPLY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TEXAS MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VASCULAR SOLUTIONS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASCULAR SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
|
Patient Problems |
MDRs with this Patient Problem |
Events in those MDRs |
No Consequences Or Impact To Patient |
1264 |
1264 |
No Clinical Signs, Symptoms or Conditions |
906 |
906 |
No Known Impact Or Consequence To Patient |
734 |
735 |
No Patient Involvement |
558 |
605 |
Foreign Body In Patient |
438 |
438 |
Occlusion |
316 |
316 |
Thrombosis |
305 |
305 |
Perforation of Vessels |
220 |
220 |
Device Embedded In Tissue or Plaque |
156 |
156 |
No Code Available |
155 |
155 |
Vessel Or Plaque, Device Embedded In |
142 |
142 |
Perforation |
141 |
141 |
Embolus |
119 |
119 |
Vascular Dissection |
111 |
111 |
Coagulation Disorder |
82 |
82 |
Pulmonary Embolism |
81 |
81 |
Death |
73 |
73 |
Pain |
61 |
61 |
No Information |
56 |
56 |
Insufficient Information |
50 |
50 |
Swelling |
50 |
50 |
Hemorrhage/Bleeding |
36 |
36 |
Chest Pain |
35 |
35 |
Foreign body, removal of |
35 |
35 |
Injury |
34 |
34 |
Stenosis |
33 |
33 |
Internal Organ Perforation |
29 |
29 |
Dyspnea |
28 |
28 |
Embolism |
28 |
28 |
Vascular System (Circulation), Impaired |
27 |
27 |
Cardiac Arrest |
25 |
25 |
Low Blood Pressure/ Hypotension |
25 |
25 |
Thrombus |
23 |
23 |
Vasoconstriction |
23 |
23 |
Air Embolism |
21 |
21 |
Pericardial Effusion |
21 |
21 |
Thrombosis/Thrombus |
20 |
20 |
Stroke/CVA |
19 |
19 |
Anxiety |
19 |
19 |
Intimal Dissection |
18 |
18 |
Myocardial Infarction |
16 |
16 |
Respiratory Distress |
16 |
16 |
Arrhythmia |
14 |
14 |
Patient Problem/Medical Problem |
14 |
14 |
Hematoma |
13 |
13 |
Blood Loss |
12 |
12 |
Cardiac Perforation |
11 |
11 |
Surgical procedure, additional |
11 |
11 |
Edema |
11 |
11 |
Obstruction/Occlusion |
11 |
11 |
Cardiac Tamponade |
10 |
10 |
Rupture |
9 |
9 |
Renal Failure |
9 |
9 |
Ventricular Fibrillation |
8 |
8 |
ST Segment Elevation |
8 |
8 |
Aortic Dissection |
8 |
8 |
Nonresorbable materials, unretrieved in body |
8 |
8 |
Calcium Deposits/Calcification |
8 |
8 |
Not Applicable |
8 |
8 |
Abdominal Pain |
7 |
7 |
Intracranial Hemorrhage |
7 |
7 |
Cardiogenic Shock |
7 |
7 |
Numbness |
7 |
7 |
Hemorrhage, Cerebral |
6 |
6 |
Ischemia |
6 |
6 |
Pseudoaneurysm |
6 |
6 |
Claudication |
5 |
5 |
Thromboembolism |
5 |
5 |
Unspecified Infection |
5 |
5 |
Fever |
5 |
5 |
Bradycardia |
5 |
5 |
Coma |
5 |
5 |
Other (for use when an appropriate patient code cannot be identified) |
5 |
5 |
Ulcer |
5 |
5 |
Dizziness |
4 |
4 |
Depression |
4 |
4 |
Pneumothorax |
4 |
4 |
Paresis |
4 |
4 |
Tachycardia |
4 |
4 |
Tissue Damage |
4 |
4 |
Cellulitis |
4 |
4 |
Aneurysm |
4 |
4 |
High Blood Pressure/ Hypertension |
4 |
4 |
Hemorrhage, Subarachnoid |
4 |
4 |
Muscle Spasm(s) |
4 |
4 |
Bowel Perforation |
4 |
4 |
Respiratory Failure |
4 |
4 |
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available |
4 |
4 |
Atrial Perforation |
3 |
3 |
Ischemia Stroke |
3 |
3 |
Muscle Weakness |
3 |
3 |
Laceration(s) |
3 |
3 |
Nausea |
3 |
3 |
Reocclusion |
3 |
3 |
Hemoptysis |
3 |
3 |
Encephalopathy |
3 |
3 |
Angina |
3 |
3 |
Infarction, Cerebral |
3 |
3 |
Cardiopulmonary Arrest |
3 |
3 |
Phlebitis |
3 |
3 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Abbott Vascular |
I |
May-19-2022 |
2 |
Angiodynamics Worldwide Headquarters |
II |
Aug-09-2012 |
3 |
Angiodynamics Worldwide Headquarters |
II |
Sep-16-2011 |
4 |
Angiodynamics, Inc. |
II |
Feb-13-2018 |
5 |
Arrow International Inc |
II |
Nov-02-2016 |
6 |
B. Braun Medical, Inc. |
II |
May-20-2016 |
7 |
Boston Scientific Corporation |
I |
Mar-25-2020 |
8 |
Boston Scientific Corporation |
II |
Jun-27-2017 |
9 |
Boston Scientific Corporation |
II |
Mar-23-2017 |
10 |
Boston Scientific Corporation |
II |
Apr-11-2012 |
11 |
Boston Scientific Corporation |
I |
Jun-10-2011 |
12 |
Boston Scientific Corporation |
II |
Jan-21-2010 |
13 |
Boston Scientific Corporation |
II |
Sep-04-2009 |
14 |
Cook Inc. |
II |
Nov-18-2019 |
15 |
Cook Inc. |
II |
Aug-22-2016 |
16 |
Cook Inc. |
I |
Feb-24-2016 |
17 |
Cook Inc. |
I |
Aug-05-2015 |
18 |
Cordis Corporation |
I |
Sep-15-2021 |
19 |
Cordis Corporation |
II |
Nov-17-2011 |
20 |
Cordis US Corp |
I |
Nov-09-2023 |
21 |
Cordis US Corp |
II |
Dec-16-2022 |
22 |
Edwards Lifesciences, LLC |
II |
Aug-12-2012 |
23 |
ICU Medical, Inc. |
II |
Oct-11-2012 |
24 |
ICU Medical, Inc. |
II |
Aug-02-2012 |
25 |
LeMaitre Vascular, Inc. |
II |
Mar-13-2017 |
26 |
Medtronic Vascular |
III |
Sep-26-2018 |
27 |
Medtronic Vascular |
II |
Apr-20-2018 |
28 |
Merit Medical Systems, Inc. |
II |
Oct-22-2013 |
29 |
Merit Medical Systems, Inc. |
II |
May-25-2013 |
30 |
Merit Medical Systems, Inc. |
II |
Dec-08-2010 |
31 |
Merit Medical Systems, Inc. |
II |
May-28-2010 |
32 |
Merit Medical Systems, Inc. |
II |
Dec-14-2009 |
33 |
Merit Medical Systems, Inc. |
III |
Jan-13-2009 |
34 |
Millar Instruments, Inc |
I |
Mar-24-2011 |
35 |
Millar Instruments, Inc |
II |
Nov-17-2010 |
36 |
Numed Inc |
II |
Nov-28-2018 |
37 |
Siemens Medical Solutions USA, Inc. |
II |
Mar-23-2011 |
38 |
Stryker Neurovascular |
II |
Jul-15-2022 |
39 |
Stryker Sustainability Solutions |
I |
Jul-22-2016 |
40 |
Stryker, Inc. |
II |
Feb-14-2024 |
41 |
Vascular Solutions, Inc. |
I |
Oct-20-2020 |
42 |
Vascular Solutions, Inc. |
I |
Apr-27-2020 |
43 |
Vascular Solutions, Inc. |
II |
Feb-23-2017 |
44 |
Vascular Solutions, Inc. |
I |
Oct-20-2016 |
45 |
Vascular Solutions, Inc. |
I |
Jul-03-2014 |
46 |
Vascular Solutions, Inc. |
II |
Jul-11-2011 |
47 |
Vascular Solutions, Inc. |
II |
Sep-28-2010 |
48 |
Volcano Corporation |
II |
Sep-12-2014 |
|
|
|
|