|
Device |
cardiac catheterization kit |
Regulation Description |
Diagnostic intravascular catheter. |
Definition |
This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance. |
Product Code | OES |
Regulation Number |
870.1200
|
Device Class |
2
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
AVID Medical, Inc. |
II |
Nov-14-2024 |
2 |
American Contract Systems |
II |
May-29-2020 |
3 |
American Contract Systems, Inc. |
II |
Sep-24-2024 |
4 |
American Contract Systems, Inc. |
II |
Jan-26-2024 |
5 |
American Contract Systems, Inc. |
II |
Oct-26-2023 |
6 |
American Contract Systems, Inc. |
II |
Sep-08-2022 |
7 |
American Contract Systems, Inc. |
II |
May-06-2022 |
8 |
Avid Medical, Inc. |
II |
Mar-19-2020 |
9 |
Cardinal Health 200, LLC |
II |
Jul-10-2024 |
10 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Dec-30-2024 |
11 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Dec-20-2024 |
12 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Dec-05-2024 |
13 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Oct-23-2024 |
14 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Aug-28-2024 |
15 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Aug-27-2024 |
16 |
MEDLINE INDUSTRIES, LP - Northfield |
I |
Aug-08-2024 |
17 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Jun-28-2024 |
18 |
MEDLINE INDUSTRIES, LP - Northfield |
I |
Feb-25-2024 |
19 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Aug-03-2023 |
20 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Jul-20-2023 |
21 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Feb-10-2023 |
22 |
MEDLINE INDUSTRIES, LP - Northfield |
II |
Feb-06-2023 |
23 |
ROi CPS LLC |
II |
Apr-25-2023 |
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