|
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
|
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
|
9
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
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
|
4
|
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
|
|
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 |
Jul-31-2024 |
5 |
Angiodynamics, Inc. |
II |
Feb-13-2018 |
6 |
Arrow International Inc |
II |
Nov-02-2016 |
7 |
B. Braun Medical, Inc. |
II |
May-20-2016 |
8 |
Boston Scientific Corporation |
I |
May-10-2024 |
9 |
Boston Scientific Corporation |
I |
Mar-25-2020 |
10 |
Boston Scientific Corporation |
II |
Jun-27-2017 |
11 |
Boston Scientific Corporation |
II |
Mar-23-2017 |
12 |
Boston Scientific Corporation |
II |
Apr-11-2012 |
13 |
Boston Scientific Corporation |
I |
Jun-10-2011 |
14 |
Boston Scientific Corporation |
II |
Jan-21-2010 |
15 |
Boston Scientific Corporation |
II |
Sep-04-2009 |
16 |
Cook Inc. |
II |
Nov-18-2019 |
17 |
Cook Inc. |
II |
Aug-22-2016 |
18 |
Cook Inc. |
I |
Feb-24-2016 |
19 |
Cook Inc. |
I |
Aug-05-2015 |
20 |
Cordis Corporation |
I |
Sep-15-2021 |
21 |
Cordis Corporation |
II |
Nov-17-2011 |
22 |
Cordis US Corp |
I |
Nov-09-2023 |
23 |
Cordis US Corp |
II |
Dec-16-2022 |
24 |
Edwards Lifesciences, LLC |
II |
Aug-12-2012 |
25 |
ICU Medical, Inc. |
II |
Oct-11-2012 |
26 |
ICU Medical, Inc. |
II |
Aug-02-2012 |
27 |
LeMaitre Vascular, Inc. |
II |
Mar-13-2017 |
28 |
Medtronic Vascular |
III |
Sep-26-2018 |
29 |
Medtronic Vascular |
II |
Apr-20-2018 |
30 |
Merit Medical Systems, Inc. |
II |
Oct-22-2013 |
31 |
Merit Medical Systems, Inc. |
II |
May-25-2013 |
32 |
Merit Medical Systems, Inc. |
II |
Dec-08-2010 |
33 |
Merit Medical Systems, Inc. |
II |
May-28-2010 |
34 |
Merit Medical Systems, Inc. |
II |
Dec-14-2009 |
35 |
Merit Medical Systems, Inc. |
III |
Jan-13-2009 |
36 |
Millar Instruments, Inc |
I |
Mar-24-2011 |
37 |
Millar Instruments, Inc |
II |
Nov-17-2010 |
38 |
Numed Inc |
II |
Nov-28-2018 |
39 |
Siemens Medical Solutions USA, Inc. |
II |
Mar-23-2011 |
40 |
Stryker Neurovascular |
II |
May-28-2024 |
41 |
Stryker Neurovascular |
II |
Jul-15-2022 |
42 |
Stryker Sustainability Solutions |
I |
Jul-22-2016 |
43 |
Stryker, Inc. |
II |
Feb-14-2024 |
44 |
Vascular Solutions, Inc. |
I |
Oct-20-2020 |
45 |
Vascular Solutions, Inc. |
I |
Apr-27-2020 |
46 |
Vascular Solutions, Inc. |
II |
Feb-23-2017 |
47 |
Vascular Solutions, Inc. |
I |
Oct-20-2016 |
48 |
Vascular Solutions, Inc. |
I |
Jul-03-2014 |
49 |
Vascular Solutions, Inc. |
II |
Jul-11-2011 |
50 |
Vascular Solutions, Inc. |
II |
Sep-28-2010 |
51 |
Volcano Corporation |
II |
Sep-12-2014 |
|
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