K234090 is an FDA 510(k) clearance for the EXPLORER AIR® II (8001, 8002, 8003). 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 March 20, 2024, 89 days after receiving the submission on December 22, 2023.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 892.1600.
| 510(k) Number | K234090 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 2023 |
| Decision Date | March 20, 2024 |
| Days to Decision | 89 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 |