FDA 510(k)

ASAHI Gladius Mongo18 PV ES

K-Number: K213868 · 2022-09-06

Decision Date2022-09-06

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI Gladius Mongo18 PV ES is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2022-09-06 under approval number K213868. 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 Gladius Mongo18 PV ES?

ASAHI Gladius Mongo18 PV ES is a medical device that received FDA 510(k) clearance on 2022-09-06. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K213868.

When was ASAHI Gladius Mongo18 PV ES approved by the FDA?

ASAHI Gladius Mongo18 PV ES received FDA 510(k) clearance on 2022-09-06, under approval number K213868.

What company makes ASAHI Gladius Mongo18 PV ES?

ASAHI Gladius Mongo18 PV ES is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for ASAHI Gladius Mongo18 PV ES?

The FDA product code for ASAHI Gladius Mongo18 PV ES 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.