|
Device |
prosthesis, esophageal |
Product Code | ESW |
Regulation Number |
878.3610
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BOSTON SCIENTIFIC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
1. K091510 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MO ...
|
2. K091816 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
|
3. K120983 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
|
4. K130004 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
|
5. K180144 Agile Esophageal Stent System
|
6. K211960 Agile Esophageal OTW Stent System
|
7. K233837 Agile Esophageal Stent System
|
BOSTON SCIENTIFIC CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
1. K091510 WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MO ...
|
2. K091816 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
|
3. K120983 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
|
4. K130004 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM
|
5. K180144 Agile Esophageal Stent System
|
6. K211960 Agile Esophageal OTW Stent System
|
7. K233837 Agile Esophageal Stent System
|
COOK IRELAND LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK IRELAND LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOCHOICE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
M.I. TECH CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
M.I. TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
M.I.TECH CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MERIT MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO-TECH (NANJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICRO-TECH (NANJING) CO.,LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAEWOONG MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAEWOONG MEDICAL CO., LTD |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
TAEWOONG MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
THORACENT, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
|
|
|