The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Umi Angiographic Catheter.
| Device ID | K851088 |
| 510k Number | K851088 |
| Device Name: | UMI ANGIOGRAPHIC CATHETER |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Contact | Charles M Copperber |
| Correspondent | Charles M Copperber UNIVERSAL MEDICAL INSTRUMENT CORP. POST OFFICE BOX 100 Ballston Spa, NY 12020 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-03-18 |
| Decision Date | 1985-05-16 |