The following data is part of a premarket notification filed by Numed, Inc. with the FDA for Numed Balloon Angiographic Catheters.
| Device ID | K864940 |
| 510k Number | K864940 |
| Device Name: | NUMED BALLOON ANGIOGRAPHIC CATHETERS |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
| Contact | Allen J Tower |
| Correspondent | Allen J Tower NUMED, INC. MAIN ST. Hopkinton, NY 12940 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-12-17 |
| Decision Date | 1987-02-19 |