The following data is part of a premarket notification filed by Med Institute, Inc. with the FDA for Flexible Dilating Sheath.
| Device ID | K945586 |
| 510k Number | K945586 |
| Device Name: | FLEXIBLE DILATING SHEATH |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MED INSTITUTE, INC. P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Neal E Fearnot |
| Correspondent | Neal E Fearnot 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 | 1994-11-14 |
| Decision Date | 1997-04-04 |
| Summary: | summary |