|
Device |
catheter, intravascular, therapeutic, short-term less than 30 days |
Product Code | FOZ |
Regulation Number |
880.5200
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACCESS VASCULAR INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACCESS VASCULAR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMECO MEDICAL INDUSTRIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARROW INTERNATION, INC. (SUBSIDIARY OF TELEFLEX INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARROW INTERNATIONAL ( A SUBSIDIARY OF TELEFLEX, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
B. BRAUN MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
B. BRAUN MELSUNGEN AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
B.BRAUN MEDICAL INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
B.BRAUN MELSUNGEN AG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BARD ACCESS SYSTEMS, INC. (BARD HAS JOINED BD) |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BARD ACCESS SYSTEMS, INC. (C.R. BARD, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON DICKINSON & CO. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON DICKINSON AND COMPANY (BD) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
BECTON, DICKINSON AND COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
BECTON, DICKINSON AND COMPANY (BARD ACCESS SYSTEMS, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECTON, DICKINSON INFUSION THERAPY SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
C.R.BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK ADVANCED TECHNOLOGIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DELTA MED SPA |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DELTA MED SRL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
EDWARDS LIFESCIENCES, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
FLEXICATH LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GLOBAL MEDIKIT LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEALTH LINE INTERNATIONAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
HEALTH LINE INTERNATIONAL CORPORATION (HLIC) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JIANGXI SANXIN MEDTEC CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JMS NORTH AMERICA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KOFU FACTORY OF TERUMO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
LUTHER NEEDLESAFE PRODUCTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIFIRST CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDIPLUS (INDIA) LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDSOURCE INTERNATIONAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDSOURCE INTERNATIONAL LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDSOURCE INTERNATIONAL, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDSOURCE INTERNATIONAL, LLC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDSOURCE LABS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SINGAPORE PTE. LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
NAVILYST MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NIPRO MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
POLY MEDICURE LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
SAUDI MAIS CO. FOR MEDICAL PRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SHINVA ANDE HEALTHCARE APPARATUS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SKYDANCE VASCULAR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
SMITHS MEDICAL ASD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TANGENT MEDICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TERUMO (PHILIPPINES) CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
TERUMO CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TERUMO MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOGO MEDIKIT CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
U.S. SAFETY SYRINGES CO., INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
UNOMEDICAL A/S |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VASCULAR PATHWAYS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VYGON |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VYGON USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WEIHAI JIERUI MEDICAL PRODUCTS CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
WOO YOUNG MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
YOMURA TECHNOLOGIES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|