The following data is part of a premarket notification filed by Mega Medical, Inc. with the FDA for Mega Angiogram Kit.
| Device ID | K913397 |
| 510k Number | K913397 |
| Device Name: | MEGA ANGIOGRAM KIT |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | MEGA MEDICAL, INC. P.O. BOX 260956 Tampa, FL 33685 |
| Contact | Ray Vahab |
| Correspondent | Ray Vahab MEGA MEDICAL, INC. P.O. BOX 260956 Tampa, FL 33685 |
| 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 | 1991-07-30 |
| Decision Date | 1991-10-31 |