The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Angiography Kit W/addit. Components.
| Device ID | K831509 |
| 510k Number | K831509 |
| Device Name: | ANGIOGRAPHY KIT W/ADDIT. COMPONENTS |
| 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 | 1983-05-11 |
| Decision Date | 1983-06-08 |