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FDA 510(k)

CardioCurve Steerable Sheath

K-Number: K210185 · 2021-07-23

ApplicantTalon Surgical
Decision Date2021-07-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CardioCurve Steerable Sheath is a medical device manufactured by Talon Surgical. It received FDA 510(k) clearance on 2021-07-23 under approval number K210185. 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 CardioCurve Steerable Sheath?

CardioCurve Steerable Sheath is a medical device that received FDA 510(k) clearance on 2021-07-23. It is manufactured by Talon Surgical. The 510(k) number is K210185.

When was CardioCurve Steerable Sheath approved by the FDA?

CardioCurve Steerable Sheath received FDA 510(k) clearance on 2021-07-23, under approval number K210185.

What company makes CardioCurve Steerable Sheath?

CardioCurve Steerable Sheath is manufactured by Talon Surgical.

What is the FDA product code for CardioCurve Steerable Sheath?

The FDA product code for CardioCurve Steerable Sheath 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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