The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Intravascular Retrieval Device.
| Device ID | K981061 |
| 510k Number | K981061 |
| Device Name: | INTRAVASCULAR RETRIEVAL DEVICE |
| Classification | Dilator, Catheter |
| Applicant | MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Neal Fearnot |
| Correspondent | Neal Fearnot MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | GCC |
| CFR Regulation Number | 878.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-23 |
| Decision Date | 1998-05-26 |
| Summary: | summary |