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FDA 510(k)

10F Sheath and Dilator Set

K-Number: K233432 · 2023-12-08

ApplicantArgon Medical Devices, Inc.
Decision Date2023-12-08
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

10F Sheath and Dilator Set is a medical device manufactured by Argon Medical Devices, Inc.. It received FDA 510(k) clearance on 2023-12-08 under approval number K233432. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 10F Sheath and Dilator Set?

10F Sheath and Dilator Set is a medical device that received FDA 510(k) clearance on 2023-12-08. It is manufactured by Argon Medical Devices, Inc.. The 510(k) number is K233432.

When was 10F Sheath and Dilator Set approved by the FDA?

10F Sheath and Dilator Set received FDA 510(k) clearance on 2023-12-08, under approval number K233432.

What company makes 10F Sheath and Dilator Set?

10F Sheath and Dilator Set is manufactured by Argon Medical Devices, Inc..

What is the FDA product code for 10F Sheath and Dilator Set?

The FDA product code for 10F Sheath and Dilator Set is DYB.

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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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