510(k) K181905 ยท PCU Pancreatic Stent, Covered, Metallic, Removable
AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, Mar 25, 2019 |
| Received | Jul 16, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181905
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 29, 2025 | Boston Scientific Corporation AXIOS Stent and Delivery System 10mmx10mm
UPN: M00553740 Open, Classified |
KNS | None listed |
| Jan 29, 2025 | Boston Scientific Corporation AXIOS Stent and Delivery System 15mmx10mm
UPN: M00553750 Open, Classified |
KNS | None listed |
| Dec 1, 2020 | Boston Scientific Corporation AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm UPN: M00553640 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pse Terminated |
PCU | None listed |
| Dec 1, 2020 | Boston Scientific Corporation AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm UPN: M00553650 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pse Terminated |
PCU | None listed |
| Dec 1, 2020 | Boston Scientific Corporation AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm UPN: M00553660 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmation of pse Terminated |
PCU | None listed |
| Dec 1, 2020 | Boston Scientific Corporation Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x10mm (OUS) UPN: M00553540 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmat Terminated |
PCU | None listed |
| Dec 1, 2020 | Boston Scientific Corporation Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 10mm x15mm (OUS) UPN: M00553550 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmat Terminated |
PCU | None listed |
| Dec 1, 2020 | Boston Scientific Corporation Hot AXIOS Stent and Electrocautery - Enhanced Delivery System 20mm x10mm (OUS) UPN: M00553560 - Product Usage: The stent is intended for implantation up to 60 days and should be removed upon confirmat Terminated |
PCU | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.