|
Device |
prosthesis, vascular graft, of 6mm and greater diameter |
Product Code | DSY |
Regulation Number |
870.3450
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ATRIUM MEDICAL CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ATRIUM MEDICAL CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEMOSHPERE, INC., A CRYOLIFE COMPANY |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HEMOSPHERE INC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
INTERVASCULAR, SAS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LEMAITRE VASCULAR, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAQUET CARDIOVASCULAR LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MAQUET CARDIOVASCULAR, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
PECA LABS |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
PECA LABS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAYSIDE FLOW TECHNOLOGIES LIMITED |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
VASCULAR FLOW TECHNOLOGIES LTD |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VASCUTEK LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K090987 VASCUTEK BRANCHED GELWEAVE
|
2. K091778 VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
|
3. K092863 MAXIFLO, TAPERFLO
|
4. K093817 GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE ...
|
5. K162794 Gelweave Vascular Grafts
|
6. K162803 Gelseal Vascular Grafts, Gelsoft Vascular Grafts, ...
|
VASCUTEK LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
1. K090987 VASCUTEK BRANCHED GELWEAVE
|
2. K091778 VASCUTEK COBRAHOOD EPTFE VASCULAR GRAFTS
|
3. K092863 MAXIFLO, TAPERFLO
|
4. K093817 GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE ...
|
5. K162794 Gelweave Vascular Grafts
|
6. K162803 Gelseal Vascular Grafts, Gelsoft Vascular Grafts, ...
|
W. L. GORE & ASSOCIATES INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
W. L. GORE & ASSOCIATES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
W.L. GORE & ASSOCIATES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
W.L. GORE & ASSOCIATES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
W.L. GORE & ASSOCIATES,INC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|