510(k) K234046 ยท MQR Stent, Colonic, Metallic, Expandable
WallFlex Colonic Stent System with Anchor Lock Delivery System; WallFlex Duodenal Stent System with Anchor Lock Delivery System; WallFlex Colonic Soft Stent System with Anchor Lock Delivery System; WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
| Applicant | Boston Scientific Corporation, Marborough MA, US |
| Decision | Substantially Equivalent, Mar 8, 2024 |
| Received | Dec 21, 2023 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K234046
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.