The following data is part of a premarket notification filed by Scanlan Intl., Inc. with the FDA for Scanlan (tm) Vein/graft Holder.
| Device ID | K864919 |
| 510k Number | K864919 |
| Device Name: | SCANLAN (TM) VEIN/GRAFT HOLDER |
| Classification | Marker, Ostia, Aorto-saphenous Vein |
| 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 | KPK |
| CFR Regulation Number | 878.4650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-16 |
| Decision Date | 1987-01-12 |