WALLSTENT ENTERAL ENDOPROSTHESIS
FDA 510(k) clearance K980113 · decided 1998-04-03
Clearance details
- K-number
- K980113
- Device name
- WALLSTENT ENTERAL ENDOPROSTHESIS
- Applicant
- Boston Scientific Scimed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-01-13
- Decision date
- 1998-04-03
- Days to decision
- 80 days
- Clearance type
- Traditional
- Product code
- MUM
- Device class
- 2
- Regulation number
- 878.3610
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Plymouth, MN, US
- Third-party review
- No
- Expedited review
- No
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| Evolution Duodenal Stent System - Uncovered, Evolution Colonic Stent System - Uncovered (K163468) | Cook Ireland, Ltd. | 2017-05-04 |
| EVOLUTION DUODENAL STENT SYSTEM, MODEL EVO-22-27-6-D, EVO-22-27-9-D, EVP-22-27-12-D (K101530) | Cook Ireland, Ltd. | 2011-03-29 |
| WALLFLEX ENTERAL DUODENAL STENT WITH ANCHOR LOCK DELIVERY SYSTEM, MODELS M00565010, M00565020, M00565030 (K062750) | Boston Scientific Corp | 2006-12-04 |
Recalls involving this device
No recalls on record reference this clearance.
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 |