The following data is part of a premarket notification filed by Medical Design Concepts, Inc. with the FDA for Heart Catheterization Tray.
| Device ID | K860161 |
| 510k Number | K860161 |
| Device Name: | HEART CATHETERIZATION TRAY |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | MEDICAL DESIGN CONCEPTS, INC. 5741 PALMER WAY Carlsbad, CA 92008 |
| Contact | Ronald Bertanzi |
| Correspondent | Ronald Bertanzi MEDICAL DESIGN CONCEPTS, INC. 5741 PALMER WAY Carlsbad, CA 92008 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-16 |
| Decision Date | 1986-05-02 |