The following data is part of a premarket notification filed by Oscor Inc. with the FDA for Angiographic Catheter, Model Angios.
| Device ID | K092118 |
| 510k Number | K092118 |
| Device Name: | ANGIOGRAPHIC CATHETER, MODEL ANGIOS |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Contact | Mila Doskocil |
| Correspondent | Mila Doskocil Oscor Inc. 3816 DE SOTO BLVD. Palm Harbor, FL 34683 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-14 |
| Decision Date | 2010-01-13 |