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FDA 510(k)

ASAHI ZENYTEEX GUIDING CATHETER

K-Number: K091188 · 2010-02-26

ApplicantAsahi Intecc Co., Ltd.
Decision Date2010-02-26
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI ZENYTEEX GUIDING CATHETER 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 2010-02-26 under 510(k) number K091188. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASAHI ZENYTEEX GUIDING CATHETER?

ASAHI ZENYTEEX GUIDING CATHETER is a medical device that received FDA 510(k) clearance on 2010-02-26. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K091188.

When did ASAHI ZENYTEEX GUIDING CATHETER receive FDA 510(k) clearance?

ASAHI ZENYTEEX GUIDING CATHETER received FDA 510(k) clearance on 2010-02-26, under 510(k) number K091188.

Who is the listed applicant for ASAHI ZENYTEEX GUIDING CATHETER?

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 ZENYTEEX GUIDING CATHETER?

The FDA product code for ASAHI ZENYTEEX GUIDING CATHETER is DQY.

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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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