The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Isleeve Introducer Set.
| Device ID | K180785 |
| 510k Number | K180785 |
| Device Name: | ISLEEVE Introducer Set |
| Classification | Introducer, Catheter |
| Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55446 |
| Contact | Toni Guidarelli |
| Correspondent | Toni Guidarelli Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55446 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-26 |
| Decision Date | 2018-06-22 |
| Summary: | summary |