FDA 510(k)

CROSSLEAD Tracker

K-Number: K241510 · 2024-08-14

Decision Date2024-08-14

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CROSSLEAD Tracker is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2024-08-14 under approval 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. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K241510.

When was CROSSLEAD Tracker approved by the FDA?

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

What company makes CROSSLEAD Tracker?

CROSSLEAD Tracker is manufactured by Asahi Intecc Co., Ltd..

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.