510(k) K962925 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
OLYMPUS B-5/B-7 SERIESBALLOON CATHETER
| Applicant | Olympus America, Inc., Melville NY, US |
| Decision | Substantially Equivalent, Oct 25, 1996 |
| Received | Jul 29, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962925
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 4, 2021 | Aomori Olympus Co., Ltd. B5-2Q BALLOON CATHETER, Model No. B5-2Q - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs. Terminated |
FGE | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. B5-2C BALLOON CATHETER 11MM DIA 2.0; Model No. B5-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs. Terminated |
FGE | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. B7-2C BALLOON CATHETER 13mm dia 2.8; model no. B7-2C - Product Usage: Used with endoscopes to inject contrast medium or other medical fluid into the bile duct, pancreatic duct, and respiratory organs. Terminated |
FGE | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. B7-2LA BALLOON CATHETER 13MM DIA 3.2, model no. B7-2LA - Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract. Terminated |
FGE | None listed |
| Jan 4, 2021 | Aomori Olympus Co., Ltd. B7-2Q BALLOON CATHETER 13MM DIA 3.2, model no. B7-2Q -Product Usage: Used with endoscopes for injection of contrast medium or other medical fluid into the biliary or pancreatic tract. Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.