|
Device |
dilator, vessel, for percutaneous catheterization |
Product Code | DRE |
Regulation Number |
870.1310
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ARSTASIS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BAYLIS MEDICAL COMPANY INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
BIOTEQUE CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CARDIACASSIST INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
COOK VASCULAR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
EDWARDS LIFESCIENCES, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GALT MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SUBSTANTIALLY EQUIVALENT - KIT
|
1
|
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MC3 INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDCOMP ( MEDICAL COMPONENTS) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDRON, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NAVILYST MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPECTRANETICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SPECTRANETICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPECTRANETICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPECTRANETICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
SUMMIT ACCESS, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOGO MEDIKIT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ULTRASONIX MEDICAL CORPATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASCULAR SOLUTIONS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
XCARDIA INNOVATION LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Angiodynamics, Inc. |
II |
Mar-21-2024 |
2 |
Argon Medical Devices, Inc |
II |
Aug-14-2020 |
3 |
Argon Medical Devices, Inc |
II |
Mar-01-2016 |
4 |
Argon Medical Devices, Inc |
II |
Jun-02-2010 |
5 |
Argon Medical Devices, Inc |
III |
Feb-02-2010 |
6 |
Boston Scientific Corporation |
II |
Nov-21-2011 |
7 |
Cardiac Assist, Inc |
II |
Apr-23-2021 |
8 |
Cordis Corporation |
II |
Jul-15-2021 |
9 |
Cordis Corporation |
II |
Mar-15-2016 |
10 |
Galt Medical Corp |
II |
May-11-2010 |
11 |
Galt Medical Corporation |
II |
Jul-27-2018 |
12 |
Maquet Cardiovascular Us Sales, Llc |
II |
Mar-27-2020 |
13 |
Merit Medical Systems, Inc. |
II |
Sep-20-2024 |
14 |
Merit Medical Systems, Inc. |
II |
Jun-22-2015 |
15 |
Merit Medical Systems, Inc. |
II |
Dec-14-2009 |
16 |
Procedure Products, Inc. |
II |
Dec-01-2015 |
|
|
|
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