K202391 is an FDA 510(k) clearance for the DIR 800. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on January 21, 2021, 153 days after receiving the submission on August 21, 2020.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K202391 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2020 |
| Decision Date | January 21, 2021 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | IZI — System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |