K214097 is an FDA 510(k) clearance for the Explorer Air II. This device is classified as a System, X-ray, Angiographic (Class II - Special Controls, product code IZI).
Submitted by Surgvision GmbH (Munich, DE). The FDA issued a Cleared decision on February 25, 2022, 59 days after receiving the submission on December 28, 2021.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K214097 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 28, 2021 |
| Decision Date | February 25, 2022 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | Summary PDF |
| Product Code | IZI - System, X-ray, Angiographic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1600 |