The following data is part of a premarket notification filed by Boston Scientific with the FDA for Isleeve Introducer Set.
| Device ID | K190184 |
| 510k Number | K190184 |
| Device Name: | ISLEEVE Introducer Set |
| Classification | Introducer, Catheter |
| Applicant | Boston Scientific Three Scimed Place Maple Grove, MN 55311 |
| Contact | Kripa Pandya |
| Correspondent | Kripa Pandya Boston Scientific Three Scimed Place Maple Grove, MN 55311 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-03-07 |