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FDA 510(k)

Multiflex Steerable Sheath

K-Number: K221655 · 2022-11-14

ApplicantVizaramed, Inc.
Decision Date2022-11-14
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Multiflex Steerable Sheath is a medical device manufactured by Vizaramed, Inc.. It received FDA 510(k) clearance on 2022-11-14 under approval number K221655. 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 Multiflex Steerable Sheath?

Multiflex Steerable Sheath is a medical device that received FDA 510(k) clearance on 2022-11-14. It is manufactured by Vizaramed, Inc.. The 510(k) number is K221655.

When was Multiflex Steerable Sheath approved by the FDA?

Multiflex Steerable Sheath received FDA 510(k) clearance on 2022-11-14, under approval number K221655.

What company makes Multiflex Steerable Sheath?

Multiflex Steerable Sheath is manufactured by Vizaramed, Inc..

What is the FDA product code for Multiflex Steerable Sheath?

The FDA product code for Multiflex Steerable Sheath is DYB.

Other Devices by Vizaramed, Inc.

K260626Multiflex Steerable Sheath 17.5F

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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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