Panels › Gastroenterology, Urology › Product code PCU · Class 2
Pancreatic Stent, Covered, Metallic, Removable
Regulation 876.5015
1510(k)s in 12 months (11 all time)
0recalls in 12 months (6 all time)
6recalls that name a 510(k)
Top companies in PCU
| Company | 510(k)s | Recalls |
|---|---|---|
| Boston Scientific Corp | 8 | 6 |
| Xlumena, Inc. | 2 | 0 |
| Taewoong Medical Co., Ltd. | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K181905 |
| 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 | K181905 |
| 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 | K181905 |
| 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 | K181905 |
| 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 | K181905 |
| 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 | K181905 |
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