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FDA 510(k)

FlexSeal Introducer Sheath with Hydrophilic Coating

K-Number: K190628 · 2019-05-30

ApplicantFreudenberg Medical Mis, Inc.
Decision Date2019-05-30
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlexSeal Introducer Sheath with Hydrophilic Coating is a medical device manufactured by Freudenberg Medical Mis, Inc.. It received FDA 510(k) clearance on 2019-05-30 under approval number K190628. 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 FlexSeal Introducer Sheath with Hydrophilic Coating?

FlexSeal Introducer Sheath with Hydrophilic Coating is a medical device that received FDA 510(k) clearance on 2019-05-30. It is manufactured by Freudenberg Medical Mis, Inc.. The 510(k) number is K190628.

When was FlexSeal Introducer Sheath with Hydrophilic Coating approved by the FDA?

FlexSeal Introducer Sheath with Hydrophilic Coating received FDA 510(k) clearance on 2019-05-30, under approval number K190628.

What company makes FlexSeal Introducer Sheath with Hydrophilic Coating?

FlexSeal Introducer Sheath with Hydrophilic Coating is manufactured by Freudenberg Medical Mis, Inc..

What is the FDA product code for FlexSeal Introducer Sheath with Hydrophilic Coating?

The FDA product code for FlexSeal Introducer Sheath with Hydrophilic Coating 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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