The following data is part of a premarket notification filed by Aesculap, Inc. with the FDA for Dir 800.
| Device ID | K202391 |
| 510k Number | K202391 |
| Device Name: | DIR 800 |
| Classification | System, X-ray, Angiographic |
| Applicant | Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Kathy A. Racosky |
| Correspondent | Kathy A. Racosky Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | IZI |
| CFR Regulation Number | 892.1600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-21 |
| Decision Date | 2021-01-21 |