The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Workstation Femoral Intravascular Retrieval (modi).
| Device ID | K914555 |
| 510k Number | K914555 |
| Device Name: | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL (MODI) |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Neal E Gearnot |
| Correspondent | Neal E Gearnot MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-07 |
| Decision Date | 1992-01-03 |