Halo One Thin-Walled Guiding Sheath
K-Number: K192313 · 2019-12-19
ApplicantC.R. Bard, Inc.
Decision Date2019-12-19
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Halo One Thin-Walled Guiding Sheath is a medical device manufactured by C.R. Bard, Inc.. It received FDA 510(k) clearance on 2019-12-19 under approval number K192313. 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 2019-12-19. It is manufactured by C.R. Bard, Inc.. The 510(k) number is K192313.
When was Halo One Thin-Walled Guiding Sheath approved by the FDA?
Halo One Thin-Walled Guiding Sheath received FDA 510(k) clearance on 2019-12-19, under approval number K192313.
What company makes Halo One Thin-Walled Guiding Sheath?
Halo One Thin-Walled Guiding Sheath is manufactured by C.R. Bard, Inc..
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.