FDA 510(k)

CROSSLEAD Penetration Peripheral Guide Wire

K-Number: K230377 · 2023-07-20

Decision Date2023-07-20

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CROSSLEAD Penetration Peripheral Guide Wire is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2023-07-20 under approval number K230377. 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 Penetration Peripheral Guide Wire?

CROSSLEAD Penetration Peripheral Guide Wire is a medical device that received FDA 510(k) clearance on 2023-07-20. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K230377.

When was CROSSLEAD Penetration Peripheral Guide Wire approved by the FDA?

CROSSLEAD Penetration Peripheral Guide Wire received FDA 510(k) clearance on 2023-07-20, under approval number K230377.

What company makes CROSSLEAD Penetration Peripheral Guide Wire?

CROSSLEAD Penetration Peripheral Guide Wire is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for CROSSLEAD Penetration Peripheral Guide Wire?

The FDA product code for CROSSLEAD Penetration Peripheral Guide Wire 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.