The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for 15f Isleeve Introducer Set, 14f Isleeve Introducer Set.
| Device ID | K191871 |
| 510k Number | K191871 |
| Device Name: | 15F ISLEEVE Introducer Set, 14F ISLEEVE Introducer Set |
| Classification | Introducer, Catheter |
| Applicant | Boston Scientific Corporation Three Scimed Place Maple Grove, MN 55311 |
| Contact | Kripa Pandya |
| Correspondent | Kripa Pandya Boston Scientific Corporation 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 | 2019-07-12 |
| Decision Date | 2019-08-07 |