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 the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2025-03-05 under 510(k) 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. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K242597.

When did CROSSLEAD 0.018inch receive FDA 510(k) clearance?

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

Who is the listed applicant for CROSSLEAD 0.018inch?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CROSSLEAD 0.018inch?

The FDA product code for CROSSLEAD 0.018inch is DQX.

Other records listing Asahi Intecc Co., Ltd. as applicant

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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.