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FDA 510(k)

CROSSLEAD Tracker

K-Number: K241510 · 2024-08-14

ApplicantAsahi Intecc Co., Ltd.
Decision Date2024-08-14
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CROSSLEAD Tracker 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 2024-08-14 under 510(k) number K241510. 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 Tracker?

CROSSLEAD Tracker is a medical device that received FDA 510(k) clearance on 2024-08-14. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K241510.

When did CROSSLEAD Tracker receive FDA 510(k) clearance?

CROSSLEAD Tracker received FDA 510(k) clearance on 2024-08-14, under 510(k) number K241510.

Who is the listed applicant for CROSSLEAD Tracker?

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 Tracker?

The FDA product code for CROSSLEAD Tracker 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.

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