The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Direxion And Direxion Hi-flo Torqueable Microcatheters.
| Device ID | K163701 |
| 510k Number | K163701 |
| Device Name: | Direxion And Direxion HI-FLO Torqueable Microcatheters |
| Classification | Catheter, Continuous Flush |
| Applicant | BOSTON SCIENTIFIC CORPORATION THREE SCIMED PLACE Maple Grove, MN 55311 |
| Contact | Liz Johnston |
| Correspondent | Liz Johnston BOSTON SCIENTIFIC CORPORATION THREE SCIMED PLACE Maple Grove, MN 55311 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-29 |
| Decision Date | 2017-05-16 |