SION blue PLUS — Asahi Intecc Co., Ltd. (510(k) K243733)
SION blue PLUS — Asahi Intecc Co., Ltd. (510(k) K243733) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: SION blue PLUS; Applicant: Asahi Intecc Co., Ltd.; Clearance track: 510(k).
| Device name | SION blue PLUS |
|---|---|
| Applicant | Asahi Intecc Co., Ltd. |
| Clearance track | 510(k) |
| Submission number | K243733 |
| Decision | Substantially Equivalent |
| Decision date | 2025-04-02 |
| Date received | 2024-12-04 |
| Product code | DQX |
| Device class | 2 |
| Medical specialty | Cardiovascular |
| Applicant location | JP |
| Source | openFDA device |
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