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FDA 510(k)

ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3

K-Number: K241158 · 2024-06-25

ApplicantAsahi Intecc Co., Ltd.
Decision Date2024-06-25
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 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 2024-06-25 under 510(k) number K241158. 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 Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3?

ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 is a medical device that received FDA 510(k) clearance on 2024-06-25. The listed applicant is Asahi Intecc Co., Ltd.. The 510(k) number is K241158.

When did ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 receive FDA 510(k) clearance?

ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 received FDA 510(k) clearance on 2024-06-25, under 510(k) number K241158.

Who is the listed applicant for ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3?

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 Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3?

The FDA product code for ASAHI Veloute; ASAHI Veloute C3; ASAHI Tellus; ASAHI Tellus C3 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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