The following data is part of a premarket notification filed by Scanlan Intl., Inc. with the FDA for Scanlan Tunneler, Sheath & Tip.
| Device ID | K851825 |
| 510k Number | K851825 |
| Device Name: | SCANLAN TUNNELER, SHEATH & TIP |
| Classification | Instruments, Surgical, Cardiovascular |
| Applicant | SCANLAN INTL., INC. ONE SCANLAN PLAZA St Paul, MN 55107 |
| Contact | Timothy M Scanlan |
| Correspondent | Timothy M Scanlan SCANLAN INTL., INC. ONE SCANLAN PLAZA St Paul, MN 55107 |
| Product Code | DWS |
| CFR Regulation Number | 870.4500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-26 |
| Decision Date | 1985-07-12 |