510(k) K133700 ยท FGE Stents, Drains And Dilators For The Biliary Ducts
ADVANIX PANCREATIC STENT AND NAVIFLEX RAPID EXCHANGE PANCREATIC DELIVERY SYSTEM AND PUSHERS
| Applicant | Boston Scientific Corporation, Marlboro MA, US |
| Decision | Substantially Equivalent, May 14, 2014 |
| Received | Dec 3, 2013 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K133700
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight
Leading Barb, 10F x 3cm
UPN: M00536610 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Boston Advanix Pancreatic Stent, Straight
Leading Barb, 10F x 4cm
UPN: M00536620 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 5cm
UPN: M00536630 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Advanix Pancreatic Stent, Straight Leading Barb, 10F x 6cm UPN: M00536640 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 7cm
UPN: M00536650 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 8cm
UPN: M00536660 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 9cm
UPN: M00536670 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 10cm
UPN: M005336680 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 11cm
UPN: M005336690 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 12cm
UPN: M00536700 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 13cm
UPN: M00536710 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 15cm
UPN: M005337206 Terminated |
FGE | None listed |
| Nov 25, 2019 | Boston Scientific Corporation Boston Scientific Advanix Pancreatic Stent, Straight Leading Barb, 10F x 18cm
UPN: M00536730 Terminated |
FGE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.