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FDA 510(k)

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension

K-Number: K163426 · 2017-04-03

ApplicantAsahi Intecc Co., Ltd.
Decision Date2017-04-03
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2017-04-03 under approval number K163426. 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 ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension?

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension is a medical device that received FDA 510(k) clearance on 2017-04-03. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K163426.

When was ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension approved by the FDA?

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension received FDA 510(k) clearance on 2017-04-03, under approval number K163426.

What company makes ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension?

ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension?

The FDA product code for ASAHI PTCA, Peripheral, and Neurovascular Guide Wires, ASAHI Guide Wire Extension 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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