The following data is part of a premarket notification filed by Scanlan Intl., Inc. with the FDA for Scanlan/taheri Valvulotome.
| Device ID | K911184 |
| 510k Number | K911184 |
| Device Name: | SCANLAN/TAHERI VALVULOTOME |
| Classification | Valvulotome |
| Applicant | SCANLAN INTL., INC. ONE SCANLAN PLAZA St Paul, MN 55107 |
| Contact | Kenneth R Blake |
| Correspondent | Kenneth R Blake SCANLAN INTL., INC. ONE SCANLAN PLAZA St Paul, MN 55107 |
| Product Code | MGZ |
| CFR Regulation Number | 870.4885 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-18 |
| Decision Date | 1992-02-18 |