Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device system, balloon, intra-aortic and control
Product CodeDSP
Regulation Number 870.3535
Device Class 2


Premarket Reviews
ManufacturerDecision
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
-
-