The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Angiography Kit.
| Device ID | K821976 |
| 510k Number | K821976 |
| Device Name: | ANGIOGRAPHY KIT |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MALLINCKRODT CRITICAL CARE 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-07-06 |
| Decision Date | 1982-07-20 |