510(k) K211934 ยท FAD Stent, Ureteral
APDL Drainage Catheter System, Flexima APDL Drainage Catheter System, Flexima APDL Drainage Catheter System Kit with Dissolving Tip, Flexima APDL Drainage Catheter System with Dissolving Tip, Flexima APD Drainage Catheter System, Flexima APD Drainage Catheter System Kit, Flexima APD Drainage Cathete
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Unknown, Nov 10, 2022 |
| Received | Jun 22, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K211934
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 13, 2024 | Boston Scientific Corporation Flexima APDL Drainage Catheter System and Kit, Material Numbers: a) REF M001271960, b) REF M001271970; all-purpose drainage catheter with locking pigtail Open, Classified |
FFA | None listed |
| Sep 13, 2024 | Boston Scientific Corporation Flexima Regular Kit Biliary Catheter System Kit, Material Numbers REF M001271650; bile drainage catheter with locking pigtail Open, Classified |
FFA | None listed |
| Sep 13, 2024 | Boston Scientific Corporation Flexima Regular Kit Nephrostomy Catheter System Kit, Material Numbers REF M001271860; To provide external drainage of the urinary tract. Open, Classified |
FFA | None listed |
| Sep 13, 2024 | Boston Scientific Corporation vanSonnenberg Sump Locking Pigtail Regular Kit Sump Catheter System Kit, Material Number REF M001273090; for use as a percutaneously placed drain for intra-abdominal fluid collections. Open, Classified |
FFA | None listed |
| Sep 13, 2024 | Boston Scientific Corporation VTC Regular Kit Nephrostomy Catheter System Kit, Material Number REF M001245300; to provide external drainage of the urinary tract. Open, Classified |
FFA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.