|
Device |
oxygenator, cardiopulmonary bypass |
Product Code | DTZ |
Regulation Number |
870.4350
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ABBOTT |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ABIOMED INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ASHITAKA FACTORY OF TERUMO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIAC ASSIST, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CHALICE MEDICAL LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
EUROSETS S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
GISH BIOMEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MAQUET CARDIOPULMONARY AG |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
MEDOS MEDIZINTECHNIK AG |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MEDTRONIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K143073 Affinity NT Oxygenator, Affinity NT Oxygenator wit ...
|
2. K162016 Affinity NT Oxygenator with Cortiva BioActive Surf ...
|
3. K162896 Affinity NT Oxygenator, Affinity NT Oxygenator wit ...
|
4. K172626 Affinity Fusion Oxygenator with Balance Biosurface ...
|
5. K172984 Affinity Pixie Oxygenator with Balance Biosurface, ...
|
6. K191029 Affinity NTTM Oxygenator (Model 511), Affinity® NT ...
|
7. K191444 Affinity NT Oxygenator with Balance Biosurface, Af ...
|
MEDTRONIC INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MEDTRONIC INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
MEDTRONIC, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K143073 Affinity NT Oxygenator, Affinity NT Oxygenator wit ...
|
2. K162016 Affinity NT Oxygenator with Cortiva BioActive Surf ...
|
3. K162896 Affinity NT Oxygenator, Affinity NT Oxygenator wit ...
|
4. K172626 Affinity Fusion Oxygenator with Balance Biosurface ...
|
5. K172984 Affinity Pixie Oxygenator with Balance Biosurface, ...
|
6. K191029 Affinity NTTM Oxygenator (Model 511), Affinity® NT ...
|
7. K191444 Affinity NT Oxygenator with Balance Biosurface, Af ...
|
MEDTRONIC, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
1. K143073 Affinity NT Oxygenator, Affinity NT Oxygenator wit ...
|
2. K162016 Affinity NT Oxygenator with Cortiva BioActive Surf ...
|
3. K162896 Affinity NT Oxygenator, Affinity NT Oxygenator wit ...
|
4. K172626 Affinity Fusion Oxygenator with Balance Biosurface ...
|
5. K172984 Affinity Pixie Oxygenator with Balance Biosurface, ...
|
6. K191029 Affinity NTTM Oxygenator (Model 511), Affinity® NT ...
|
7. K191444 Affinity NT Oxygenator with Balance Biosurface, Af ...
|
QURA S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SORIN GROUP ITALIA S.R.L |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SORIN GROUP ITALIA S.R.L. |
|
SUBSTANTIALLY EQUIVALENT
|
15
|
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
TERUMO CARDIOVASCULAR SYSTEMS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
TERUMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Abiomed, Inc. |
I |
Feb-03-2022 |
2 |
GETINGE US SALES LLC |
II |
Dec-12-2019 |
3 |
LivaNova USA |
II |
May-23-2018 |
4 |
Maquet Cardiovascular Us Sales, Llc |
II |
Dec-17-2020 |
5 |
Maquet Cardiovascular Us Sales, Llc |
II |
Sep-13-2019 |
6 |
Maquet Cardiovascular Us Sales, Llc |
I |
Nov-28-2018 |
7 |
Maquet Cardiovascular Us Sales, Llc |
II |
Apr-12-2016 |
8 |
Maquet Cardiovascular Us Sales, Llc |
II |
May-28-2015 |
9 |
Maquet Cardiovascular Us Sales, Llc |
II |
Dec-24-2014 |
10 |
Maquet Cardiovascular Us Sales, Llc |
II |
Sep-20-2013 |
11 |
Maquet Cardiovascular Us Sales, Llc |
II |
Oct-26-2012 |
12 |
Maquet Cardiovascular Us Sales, Llc |
II |
Jan-11-2012 |
13 |
Maquet Medical Systems USA |
II |
Feb-13-2024 |
14 |
Maquet Medical Systems USA |
II |
May-30-2023 |
15 |
Maquet Medical Systems USA |
II |
May-26-2023 |
16 |
Maquet Medical Systems USA |
II |
Feb-28-2023 |
17 |
Maquet Medical Systems USA |
II |
Sep-19-2022 |
18 |
Medtronic Inc |
II |
Dec-20-2016 |
19 |
Medtronic Inc |
II |
Feb-09-2009 |
20 |
Medtronic Inc. Cardiac Rhythm Disease Management |
II |
Aug-27-2013 |
21 |
Medtronic Inc. Cardiac Rhythm Disease Management |
II |
Jan-18-2012 |
22 |
Medtronic Perfusion Systems |
II |
Jan-27-2023 |
23 |
Medtronic Perfusion Systems |
II |
Jul-04-2020 |
24 |
Medtronic Perfusion Systems |
II |
Dec-16-2014 |
25 |
Sorin Group USA, Inc. |
II |
Jan-14-2012 |
26 |
Terumo Cardiovascular Corporation |
III |
Jan-24-2012 |
27 |
Terumo Cardiovascular Systems Corp |
II |
May-11-2012 |
28 |
Terumo Cardiovascular Systems Corporation |
II |
Apr-05-2023 |
29 |
Terumo Cardiovascular Systems Corporation |
II |
Dec-14-2020 |
30 |
Terumo Cardiovascular Systems Corporation |
II |
Jul-30-2019 |
|
|
|
|