FDA 510(k)

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16

K-Number: K161584 · 2016-10-06

Decision Date2016-10-06

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2016-10-06 under approval number K161584. 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® Peripheral Vascular Guide Wire ASAHI Meister®16?

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 is a medical device that received FDA 510(k) clearance on 2016-10-06. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K161584.

When was ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 approved by the FDA?

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 received FDA 510(k) clearance on 2016-10-06, under approval number K161584.

What company makes ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16?

ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16?

The FDA product code for ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 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.