The following data is part of a premarket notification filed by Medical Engineering And Development Institute with the FDA for Workstation Femoral Intravascular Retrieval Set.
| Device ID | K902477 |
| 510k Number | K902477 |
| Device Name: | WORKSTATION FEMORAL INTRAVASCULAR RETRIEVAL SET |
| Classification | Introducer, Catheter |
| Applicant | MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE P.O. BOX 2402 West Lafayette, IN 47906 |
| Contact | Fearnot, Phd |
| Correspondent | Fearnot, Phd MEDICAL ENGINEERING AND DEVELOPMENT INSTITUTE P.O. BOX 2402 West Lafayette, IN 47906 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-04 |
| Decision Date | 1990-08-24 |