FDA 510(k)

SION blue PLUS

K-Number: K243733 · 2025-04-02

Decision Date2025-04-02

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

SION blue PLUS is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-04-02 under approval number K243733. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SION blue PLUS?

SION blue PLUS is a medical device that received FDA 510(k) clearance on 2025-04-02. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K243733.

When was SION blue PLUS approved by the FDA?

SION blue PLUS received FDA 510(k) clearance on 2025-04-02, under approval number K243733.

What company makes SION blue PLUS?

SION blue PLUS is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for SION blue PLUS?

The FDA product code for SION blue PLUS is DQX.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.