The following data is part of a premarket notification filed by Boston Scientific Coporation with the FDA for Mamba And Mamba Flex Microcatheters.
| Device ID | K190401 |
| 510k Number | K190401 |
| Device Name: | MAMBA And MAMBA Flex Microcatheters |
| Classification | Catheter, Percutaneous |
| Applicant | Boston Scientific Coporation Three Scimed Place Maple Grove, MN 55311 |
| Contact | Kevin Catalano |
| Correspondent | Kevin Catalano Boston Scientific Coporation Three Scimed Place Maple Grove, MN 55311 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-19 |
| Decision Date | 2019-03-15 |