The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Rotatable Snares.
| Device ID | K160637 |
| 510k Number | K160637 |
| Device Name: | Rotatable Snares |
| Classification | Snare, Flexible |
| Applicant | BOSTON SCIENTIFIC CORPORATION 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Michael Secondini |
| Correspondent | Michael Secondini BOSTON SCIENTIFIC CORPORATION 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | FDI |
| CFR Regulation Number | 876.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-03-07 |
| Decision Date | 2016-03-30 |
| Summary: | summary |