FDA 510(k)

CROSSLEAD 0.018inch

K-Number: K242597 · 2025-03-05

Decision Date2025-03-05

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CROSSLEAD 0.018inch is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-03-05 under approval number K242597. 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 CROSSLEAD 0.018inch?

CROSSLEAD 0.018inch is a medical device that received FDA 510(k) clearance on 2025-03-05. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K242597.

When was CROSSLEAD 0.018inch approved by the FDA?

CROSSLEAD 0.018inch received FDA 510(k) clearance on 2025-03-05, under approval number K242597.

What company makes CROSSLEAD 0.018inch?

CROSSLEAD 0.018inch is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for CROSSLEAD 0.018inch?

The FDA product code for CROSSLEAD 0.018inch 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.