The following data is part of a premarket notification filed by Medicomp, Inc. with the FDA for Epicardia 4000.
| Device ID | K900207 |
| 510k Number | K900207 |
| Device Name: | EPICARDIA 4000 |
| Classification | Clip, Vena-cava |
| Applicant | MEDICOMP, INC. 7845 ELLIS RD. West Melbourne, FL 32904 |
| Contact | David J Plummer |
| Correspondent | David J Plummer MEDICOMP, INC. 7845 ELLIS RD. West Melbourne, FL 32904 |
| Product Code | DST |
| CFR Regulation Number | 870.3260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-01-16 |
| Decision Date | 1990-07-31 |