|
Device |
introducer, catheter |
Regulation Description |
Catheter introducer. |
Product Code | DYB |
Regulation Number |
870.1340
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABIOMED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ABIOMED INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ABIOMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACCESS SCIENTIFIC, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
ALSEAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ANGIODYNAMICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARGON MEDICAL DEVICES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARGON MEDICAL DEVICES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BAYLIS MEDICAL COMPANY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
BIOCARDIA, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSENSE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOSENSE WEBSTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BOSTON SCIENTIFIC CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
CONTRACT MEDICAL INTL. GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COOK, INC. |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
|
SUBSTANTIALLY EQUIVALENT
|
10
|
CORDIS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
CORDIS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EDWARDS LIFESCIENCES |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EDWARDS LIFESCIENCES LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOPHYS HOLDINGS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ENDOPHYS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GALT MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
GREATBATCH MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KALILA MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LEPU MEDICAL TECHNOLOGY (BEIJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
MEDCOMP (MEDICAL COMPONENTS, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC VASCULAR |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC VASCULAR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDTRONIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NUMED, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ONSET MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHANGHAI KINDLY MEDICAL INSTRUMENTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ST. JUDE MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SURMODICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO CARDIOVASCULAR SYSTEMS |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
TERUMO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
THERAGENICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
VASCULAR SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
W.L. GORE & ASSOCIATES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
W.L. GORE & ASSOCIATES,INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
MDR Year |
MDR Reports |
MDR Events |
2016 |
1233 |
1233 |
2017 |
1668 |
1668 |
2018 |
1899 |
1899 |
2019 |
2449 |
2449 |
2020 |
2465 |
2465 |
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Abbott Medical |
II |
Jan-08-2020 |
2 |
Abbott Medical |
II |
Jan-07-2020 |
3 |
Acutus Medical Inc |
II |
Apr-23-2020 |
4 |
Angiodynamics Inc. (Navilyst Medical Inc.) |
II |
Jun-14-2018 |
5 |
Angiodynamics, Inc. |
II |
Dec-16-2016 |
6 |
Angiodynamics, Inc. |
III |
Dec-16-2016 |
7 |
Argon Medical Devices, Inc |
II |
Oct-07-2016 |
8 |
Arrow International Inc |
II |
Feb-14-2020 |
9 |
Arrow International Inc |
II |
Sep-23-2019 |
10 |
Arrow International Inc |
II |
Jul-30-2018 |
11 |
Arrow International Inc |
II |
May-30-2018 |
12 |
Arrow International Inc |
II |
Apr-10-2018 |
13 |
Arrow International Inc |
II |
Apr-02-2018 |
14 |
Arrow International Inc |
II |
Mar-05-2018 |
15 |
Arrow International Inc |
II |
Jun-27-2017 |
16 |
Arrow International Inc |
II |
Jun-12-2017 |
17 |
Arrow International Inc |
II |
Mar-07-2016 |
18 |
BARD PERIPHERAL VASCULAR, INC |
I |
Jan-18-2017 |
19 |
Baylis Medical Company Inc. |
II |
May-21-2020 |
20 |
Cook Inc. |
I |
Dec-23-2020 |
21 |
Cook Inc. |
II |
Feb-20-2019 |
22 |
Cook Inc. |
II |
Mar-02-2017 |
23 |
Cook Inc. |
II |
Aug-22-2016 |
24 |
Cook Inc. |
II |
Feb-24-2016 |
25 |
Creganna Medical Devices |
II |
Jun-14-2017 |
26 |
Galt Medical Corporation |
II |
Jul-27-2018 |
27 |
Greatbatch Medical |
II |
Jul-29-2017 |
28 |
Greatbatch Medical |
II |
Jul-29-2017 |
29 |
Greatbatch Medical |
II |
Nov-18-2016 |
30 |
Kalila Medical |
II |
Feb-09-2018 |
31 |
Medical Components, Inc dba MedComp |
II |
Jun-07-2016 |
32 |
Medtronic Vascular Galway DBA Medtronic Ireland |
I |
May-27-2020 |
33 |
Merit Medical Systems, Inc. |
II |
May-11-2020 |
34 |
Merit Medical Systems, Inc. |
II |
Feb-22-2018 |
35 |
Merit Medical Systems, Inc. |
I |
Mar-24-2017 |
36 |
Merit Medical Systems, Inc. |
II |
Jan-05-2017 |
37 |
Oscor, Inc. |
II |
Dec-19-2016 |
38 |
Sterilmed Inc |
I |
Dec-29-2017 |
39 |
Terumo Medical Corp |
II |
Dec-08-2017 |
40 |
Terumo Medical Corporation |
I |
May-28-2019 |
41 |
Terumo Medical Corporation |
II |
Feb-26-2018 |
42 |
Terumo Medical Corporation |
II |
May-04-2017 |
43 |
Terumo Medical Corporation |
II |
Sep-06-2016 |
44 |
W. L. Gore & Associates Inc. |
II |
May-11-2020 |
|
|
|
|