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FDA 510(k)

CROSSLEAD Peripheral Guide Wire

K-Number: K213315 · 2022-07-01

ApplicantAsahi Intecc Co., Ltd.
Decision Date2022-07-01
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CROSSLEAD Peripheral Guide Wire is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2022-07-01 under approval number K213315. 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 Peripheral Guide Wire?

CROSSLEAD Peripheral Guide Wire is a medical device that received FDA 510(k) clearance on 2022-07-01. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K213315.

When was CROSSLEAD Peripheral Guide Wire approved by the FDA?

CROSSLEAD Peripheral Guide Wire received FDA 510(k) clearance on 2022-07-01, under approval number K213315.

What company makes CROSSLEAD Peripheral Guide Wire?

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

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

The FDA product code for CROSSLEAD 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.

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