|
Device |
stents, drains and dilators for the biliary ducts |
Regulation Description |
Biliary catheter and accessories. |
Product Code | FGE |
Regulation Number |
876.5010
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
ASAHI INTECC CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIOTEQUE CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BOSTON SCIENTIFIC |
|
SE - WITH LIMITATIONS
|
2
|
BOSTON SCIENTIFIC CORPORATION |
|
SE - WITH LIMITATIONS
|
1
|
|
SUBSTANTIALLY EQUIVALENT
|
2
|
COOK IRELAND LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
COOK IRELAND LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DONGGUAN TT MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDO GI MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOGI MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ENDOGI MEDICAL, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
SE - WITH LIMITATIONS
|
1
|
JIANGSU VEDKANG MEDICAL SCIENCE AND TECHNOLOGY CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
LEO MEDICAL CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
M.I.TECH CO., LTD. |
|
SE - WITH LIMITATIONS
|
1
|
MICRO-TECH (NANJING) CO., LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
1. K211021 Sterile Biliary Stone Retrieval Balloon Catheter, ...
|
2. K230127 Biliary Plastic Stent, Biliary Plastic Stent Intro ...
|
S&G BIOTECH INC. |
|
SE - WITH LIMITATIONS
|
1
|
TAEWOONG MEDICAL CO., LTD |
|
SE - WITH LIMITATIONS
|
2
|
|
|
|
|