FDA 510(k)

ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20

K-Number: K211898 · 2021-12-08

Decision Date2021-12-08

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 is the device name listed in this FDA 510(k) record. The listed applicant is Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2021-12-08 under 510(k) number K211898. 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 PCI Guide Wire ASAHI CONFIANZA PRO 8-20?

ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 is a medical device that received FDA 510(k) clearance on 2021-12-08. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K211898.

When did ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 receive FDA 510(k) clearance?

ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 received FDA 510(k) clearance on 2021-12-08, under 510(k) number K211898.

Who is the listed applicant for ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20?

The FDA 510(k) record lists Asahi Intecc Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20?

The FDA product code for ASAHI PCI Guide Wire ASAHI CONFIANZA PRO 8-20 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.