510(k) K190401 ยท DQY Catheter, Percutaneous
MAMBA and MAMBA Flex Microcatheters
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Mar 15, 2019 |
| Received | Feb 19, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190401
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 5, 2021 | Boston Scientific Corporation MAMBA Flex 135 Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are appl Terminated |
DQY | None listed |
| Mar 5, 2021 | Boston Scientific Corporation MAMBA Microcatheter. Packaged with protective sleeve over catheter, sealed in a Tyvek pouch, and is then labeled and placed in carton with IFU. A closure strip, top and side labels are applied to th Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.