The following data is part of a premarket notification filed by Xlumena, Inc. with the FDA for Axios Stent And Delivery System (with 10mm X 10mm Stent) Axios Stent And Delivery System (with 15mm X 10mm Stent).
| Device ID | K140561 |
| 510k Number | K140561 |
| Device Name: | AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) |
| Classification | Pancreatic Stent, Covered, Metallic, Removable |
| Applicant | XLUMENA, INC. 453 RAVENDALE DRIVE. SUITE H Mountain View, CA 94043 |
| Contact | Jane Beggs |
| Correspondent | Jane Beggs XLUMENA, INC. 453 RAVENDALE DRIVE. SUITE H Mountain View, CA 94043 |
| Product Code | PCU |
| CFR Regulation Number | 876.5015 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-03-05 |
| Decision Date | 2014-04-23 |
| Summary: | summary |