510(k) K152572
- Device
- AXIOS Stent And Delivery System
- Applicant
- BOSTON SCIENTIFIC CORPORATION
- 510(k) number
- K152572
- Product code
- PCU
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2015-10-06
- Date received
- 2015-09-09
- Regulation
- 876.5015
- Classification name
- Pancreatic Stent, Covered, Metallic, Removable
- Medical specialty
- Gastroenterology/Urology
- Review panel
- Gastroenterology/Urology
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ASHLEY SANTOS
- Address
- 453 Ravendale Dr., Suite H Mountain View CA US 94043 94043
FDA Registration Numbers#
- 2024311
- 3003902943
- 3010273872
- 3005099803
- 1000121056
- 9681260
- 3002807314
Source Documents#
Other 510(k) Records For Product Code PCU #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252648 | Niti-S SPAXUS Stent | Taewoong Medical Co., Ltd. | 2026-03-13 |
| K220112 | AXIOS Stent and Electrocautery-Enhanced Delivery System | Boston Scientific Corporation | 2022-09-07 |
| K203132 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2021-04-15 |
| K192043 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2019-08-26 |
| K181905 | AXIOS Stent and Delivery System, AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2019-03-25 |
| K163272 | AXIOS Stent and Electrocautery Enhanced Delivery System | Boston Scientific Corporation | 2017-02-18 |
| K153088 | AXIOS Stent with Delivery System, AXIOS Stent with Electro-cautery Enhanced Delivery System | Boston Scientific Corporation | 2015-12-11 |
| K150692 | AXIOS Stent with Electrocautery Enhanced Delivery System | Boston Scientific Corp | 2015-08-05 |
| K140561 | AXIOS STENT AND DELIVERY SYSTEM (WITH 10MM X 10MM STENT) AXIOS STENT AND DELIVERY SYSTEM (WITH 15MM X 10MM STENT) | Xlumena, Inc. | 2014-04-23 |
| DEN130007 | AXIOS STENT AND DELIVERY SYSTEM | Xlumena, Inc. | 2013-12-18 |
Legacy Summary#
summary
FDA Review#
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