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FDA 510(k)

Drakon and Sequre Microcatheters

K-Number: K202797 · 2020-10-23

ApplicantAccurate Medical Therapeutics, Ltd.
Decision Date2020-10-23
Product CodeDQO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Drakon and Sequre Microcatheters is a medical device manufactured by Accurate Medical Therapeutics, Ltd.. It received FDA 510(k) clearance on 2020-10-23 under approval number K202797. The device is classified under product code DQO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Drakon and Sequre Microcatheters?

Drakon and Sequre Microcatheters is a medical device that received FDA 510(k) clearance on 2020-10-23. It is manufactured by Accurate Medical Therapeutics, Ltd.. The 510(k) number is K202797.

When was Drakon and Sequre Microcatheters approved by the FDA?

Drakon and Sequre Microcatheters received FDA 510(k) clearance on 2020-10-23, under approval number K202797.

What company makes Drakon and Sequre Microcatheters?

Drakon and Sequre Microcatheters is manufactured by Accurate Medical Therapeutics, Ltd..

What is the FDA product code for Drakon and Sequre Microcatheters?

The FDA product code for Drakon and Sequre Microcatheters is DQO.

Other Devices by Accurate Medical Therapeutics, Ltd.

K173430SeQure® NF and SeQure® Microcatheters K203487Drakon and Sequre Microcatheters

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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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