The following data is part of a premarket notification filed by Boston Scientific Inc. with the FDA for Savion Dlvr Guidewire, Savion Flx Guidewire.
| Device ID | K180726 |
| 510k Number | K180726 |
| Device Name: | Savion DLVR Guidewire, Savion FLX Guidewire |
| Classification | Wire, Guide, Catheter |
| Applicant | Boston Scientific Inc. Three Scimed Place Maple Grove, MN 55311 |
| Contact | Jake Baldauf |
| Correspondent | Jake Baldauf Boston Scientific Inc. Three Scimed Place Maple Grove, MN 55311 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-20 |
| Decision Date | 2018-06-18 |
| Summary: | summary |