|
Device |
catheter, intravascular, therapeutic, long-term greater than 30 days |
Product Code | LJS |
Regulation Number |
880.5970
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ACCESS VASCULAR INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ACCESS VASCULAR, INC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ARROW INTERNATIONAL, LLC (A SUBSIDIARY OF TELEFLEX, INC.) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BARD ACCESS SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BIOWY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
C.R. BARD, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC (BARD HAS JOINED BD) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C.R. BARD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COOK INCORPORATED |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
JET MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MEDICAL COMPONENTS, INC. (DBA MEDCOMP) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PICCOLO MEDICAL, INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PIPER ACCESS LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VYGON USA |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|