WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
FDA 510(k) clearance K964119 · decided 1997-04-28
Clearance details
- K-number
- K964119
- Device name
- WALLSTENT TRANSHEPATIC BILIARY ENDOPROSTHESIS
- Applicant
- Boston Scientific Scimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-15
- Decision date
- 1997-04-28
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- FGE
- Device class
- 2
- Regulation number
- 876.5010
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Wallstent Endoscopic Biliary Endoprosthesis- 8mm x 40mm, UPN H965430100 recall (Z-0604-2007) | Boston Scientific Corporation | 2007-03-13 |
| Wallstent Endoscopic Biliary Endoprosthesis 8mm x 60mm, UPN H965430200 recall (Z-0605-2007) | Boston Scientific Corporation | 2007-03-13 |
| Wallstent Endoscopic Biliary Endoprosthesis 8mm x 80mm, UPN H965430300 recall (Z-0606-2007) | Boston Scientific Corporation | 2007-03-13 |
| Wallstent Endoscopic Biliary Endoprosthesis 10mm x 40mm, UPN H965430400 recall (Z-0607-2007) | Boston Scientific Corporation | 2007-03-13 |
| Wallstent Endoscopic Biliary Endoprosthesis 10mm x 60mm, UPN H965430500 recall (Z-0608-2007) | Boston Scientific Corporation | 2007-03-13 |
| Wallstent Endoscopic Biliary Endoprosthesis 10mm x 80mm, UPN H965430600 recall (Z-0609-2007) | Boston Scientific Corporation | 2007-03-13 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S066) | Boston Scientific Scimed, Inc. | 2024-06-27 |
| Wallstent ILIAC RP Endoprosthesis (P940019/S065) | Boston Scientific Scimed, Inc. | 2024-03-13 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S064) | Boston Scientific Scimed, Inc. | 2024-02-20 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S063) | Boston Scientific Scimed, Inc. | 2023-06-14 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S062) | Boston Scientific Scimed, Inc. | 2022-11-28 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S061) | Boston Scientific Scimed, Inc. | 2022-11-22 |
| WALLSTENT ILIAC RP Endoprosthesis (P940019/S060) | Boston Scientific Scimed, Inc. | 2022-06-28 |
| Wallstent Iliac Endoprosthesis With Unistep Plus Delivery System (P940019/S059) | Boston Scientific Scimed, Inc. | 2020-07-22 |