FDA 510(k)

Halo One Thin-Walled Guiding Sheath

K-Number: K212708 · 2021-09-23

Decision Date2021-09-23

Product CodeDYB

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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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.