The following data is part of a premarket notification filed by Clinipad Corp. with the FDA for Cardiac Catheterization Tray.
| Device ID | K931560 |
| 510k Number | K931560 |
| Device Name: | CARDIAC CATHETERIZATION TRAY |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
| Contact | Patricia Stawarz |
| Correspondent | Patricia Stawarz CLINIPAD CORP. 66 HIGH ST. P.O. BOX 387 Guilford, CT 06437 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-30 |
| Decision Date | 1994-07-11 |