FDA 510(k) Applications for Medical Device Product Code "PCU"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K150692 | BOSTON SCIENTIFIC CORP. | AXIOS Stent with Electrocautery Enhanced Delivery System | 08/05/2015 |
| K152572 | BOSTON SCIENTIFIC CORPORATION | AXIOS Stent and Delivery System | 10/06/2015 |
| K181905 | Boston Scientific Corporation | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System | 03/25/2019 |
| K203132 | Boston Scientific Corporation | AXIOS Stent and Electrocautery Enhanced Delivery System | 04/15/2021 |
| K163272 | Boston Scientific Corporation | AXIOS Stent and Electrocautery Enhanced Delivery System | 02/18/2017 |
| K192043 | Boston Scientific Corporation | AXIOS Stent and Electrocautery Enhanced Delivery System | 08/26/2019 |
| K220112 | Boston Scientific Corporation | AXIOS Stent and Electrocautery-Enhanced Delivery System | 09/07/2022 |
| K153088 | BOSTON SCIENTIFIC CORPORATION | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System | 12/11/2015 |
| DEN130007 | XLUMENA, INC | AXIOS STENT AND DELIVERY SYSTEM | 12/18/2013 |
| K140561 | XLUMENA, INC. | AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) | 04/23/2014 |
Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact
