FDA 510(k)

Halo One Thin-Walled Guiding Sheath

Numéro K : K212708 · 2021-09-23

Date de décision2021-09-23

Code produitDYB

Comité consultatifCV

DécisionSubstantially Equivalent

Résumé du dispositif

Halo One Thin-Walled Guiding Sheath is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2021-09-23 under 510(k) number K212708. 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 Halo One Thin-Walled Guiding Sheath?

Halo One Thin-Walled Guiding Sheath is a medical device that received FDA 510(k) clearance on 2021-09-23. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K212708.

When did Halo One Thin-Walled Guiding Sheath receive FDA 510(k) clearance?

Halo One Thin-Walled Guiding Sheath received FDA 510(k) clearance on 2021-09-23, under 510(k) number K212708.

Who is the listed applicant for Halo One Thin-Walled Guiding Sheath?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Halo One Thin-Walled Guiding Sheath?

The FDA product code for Halo One Thin-Walled Guiding Sheath is DYB.

Essais cliniques associés

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Source officielle

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