FDA 510(k)

FlexSeal Introducer Sheath with Hydrophilic Coating

Numéro K : K190628 · 2019-05-30

Date de décision2019-05-30

Code produitDYB

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

FlexSeal Introducer Sheath with Hydrophilic Coating is the device name listed in this FDA 510(k) record. The listed applicant is Freudenberg Medical Mis, Inc.. It received FDA 510(k) clearance on 2019-05-30 under 510(k) number K190628. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

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. The listed applicant is Freudenberg Medical Mis, Inc.. The 510(k) number is K190628.

When did FlexSeal Introducer Sheath with Hydrophilic Coating receive FDA 510(k) clearance?

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

Who is the listed applicant for FlexSeal Introducer Sheath with Hydrophilic Coating?

The FDA 510(k) record lists Freudenberg Medical Mis, Inc. as the applicant. This does not by itself establish the device manufacturer.

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.

Essais cliniques associés

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Dispositifs connexes (Code : DYB)

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Source officielle

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