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FDA 510(k)

ASAHI PTCA Guide Wire ASAHI SION black

K-Number: K173277 · 2018-07-05

ApplicantAsahi Intecc Co., Ltd.
Decision Date2018-07-05
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI PTCA Guide Wire ASAHI SION black is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2018-07-05 under approval number K173277. 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 Guide Wire ASAHI SION black?

ASAHI PTCA Guide Wire ASAHI SION black is a medical device that received FDA 510(k) clearance on 2018-07-05. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K173277.

When was ASAHI PTCA Guide Wire ASAHI SION black approved by the FDA?

ASAHI PTCA Guide Wire ASAHI SION black received FDA 510(k) clearance on 2018-07-05, under approval number K173277.

What company makes ASAHI PTCA Guide Wire ASAHI SION black?

ASAHI PTCA Guide Wire ASAHI SION black is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for ASAHI PTCA Guide Wire ASAHI SION black?

The FDA product code for ASAHI PTCA Guide Wire ASAHI SION black 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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