The following data is part of a premarket notification filed by Medi-plast Intl., Inc. with the FDA for Heart Catheterization Tray Set.
| Device ID | K840022 |
| 510k Number | K840022 |
| Device Name: | HEART CATHETERIZATION TRAY SET |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MEDI-PLAST INTL., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-05 |
| Decision Date | 1984-02-04 |