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TPLC
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Device
system, balloon, intra-aortic and control
Product Code
DSP
Regulation Number
870.3535
Device Class
2
Premarket Reviews
Manufacturer
Decision
ARROW INTERNATIONAL INC.
SUBSTANTIALLY EQUIVALENT
2
ARROW INTERNATIONAL, INC.
SUBSTANTIALLY EQUIVALENT
3
ARROW INTERNATIONAL, LLC
SUBSTANTIALLY EQUIVALENT
1
ARROW INTERNATIONAL, TELEFLEX
SUBSTANTIALLY EQUIVALENT
1
CARDIAC ASSIST, MAQUET CARDIOVASCULAR LLC
SUBSTANTIALLY EQUIVALENT
2
DATASCOPE CORP.
SUBSTANTIALLY EQUIVALENT
5
DATASCOPE CORP., CARDIAC ASSIST DIVISION
SUBSTANTIALLY EQUIVALENT
3
INSIGHTRA MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
1
Recalls
Manufacturer
Recall Class
Date Posted
1
ARROW INTERNATIONAL Inc.
I
Jun-03-2024
2
ARROW INTERNATIONAL Inc.
I
Dec-15-2022
3
Arrow International Inc
I
Jun-26-2020
4
Arrow International Inc
II
Mar-10-2015
5
Arrow International Inc
II
Mar-02-2015
6
Arrow International Inc
II
Apr-06-2013
7
Arrow International, Inc.
I
Apr-16-2009
8
Arrow International, Inc., Division of Teleflex Medical Inc.
I
Mar-11-2016
9
Arrow International, Inc., Division of Teleflex Medical Inc.
I
Dec-23-2010
10
Datascope Corp.
II
Aug-31-2023
11
Datascope Corp.
I
Aug-30-2023
12
Datascope Corp.
I
Aug-30-2023
13
Datascope Corp.
I
Aug-30-2023
14
Datascope Corp.
I
Aug-30-2023
15
Datascope Corp.
II
Jul-21-2023
16
Datascope Corp.
I
Jul-20-2023
17
Datascope Corp.
I
Jul-19-2023
18
Datascope Corp.
III
Jun-14-2023
19
Datascope Corp.
II
Apr-26-2023
20
Datascope Corp.
II
Mar-22-2023
21
Datascope Corp.
I
Mar-09-2023
22
Datascope Corp.
I
Mar-09-2023
23
Datascope Corp.
II
Mar-06-2023
24
Datascope Corp.
II
Mar-06-2023
25
Datascope Corp.
I
Jan-19-2023
26
Datascope Corp.
I
Dec-30-2021
27
Datascope Corp.
I
Oct-20-2021
28
Datascope Corp.
II
Oct-07-2021
29
Datascope Corp.
II
Sep-30-2021
30
Datascope Corp.
III
Apr-28-2021
31
Datascope Corp.
I
Jul-16-2019
32
Datascope Corporation
II
Sep-08-2022
33
Datascope Corporation
II
Aug-21-2020
34
Datascope Corporation
II
Feb-02-2020
35
Datascope Corporation
II
Jul-12-2019
36
Datascope Corporation
II
Oct-11-2018
37
Datascope Corporation
II
Apr-16-2018
38
Datascope Corporation
II
Jun-08-2016
39
Datascope Corporation
III
Sep-03-2014
40
Datascope Corporation
II
Jun-21-2010
41
Datascope Corporation
II
Apr-15-2009
42
Maquet Cardiovascular, LLC
II
Jan-09-2013
43
Maquet Datascope Corp - Cardiac Assist Division
I
Oct-27-2018
44
Maquet Datascope Corp - Cardiac Assist Division
I
May-31-2018
45
Maquet Datascope Corp - Cardiac Assist Division
I
Sep-05-2017
46
Maquet Datascope Corp - Cardiac Assist Division
I
Jun-23-2017
47
Maquet Datascope Corp - Cardiac Assist Division
II
Mar-02-2017
48
Maquet Datascope Corp - Cardiac Assist Division
II
Mar-25-2016
49
Maquet Datascope Corp - Cardiac Assist Division
II
Feb-23-2015
50
Maquet Datascope Corp - Cardiac Assist Division
II
Feb-07-2015
51
Maquet Datascope Corp - Cardiac Assist Division
I
May-21-2014
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