Multiflex Steerable Sheath 17.5F
K-Number: K260626 · 2026-03-26
ApplicantVizaramed, Inc.
Decision Date2026-03-26
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Multiflex Steerable Sheath 17.5F is a medical device manufactured by Vizaramed, Inc.. It received FDA 510(k) clearance on 2026-03-26 under approval number K260626. 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 Multiflex Steerable Sheath 17.5F?
Multiflex Steerable Sheath 17.5F is a medical device that received FDA 510(k) clearance on 2026-03-26. It is manufactured by Vizaramed, Inc.. The 510(k) number is K260626.
When was Multiflex Steerable Sheath 17.5F approved by the FDA?
Multiflex Steerable Sheath 17.5F received FDA 510(k) clearance on 2026-03-26, under approval number K260626.
What company makes Multiflex Steerable Sheath 17.5F?
Multiflex Steerable Sheath 17.5F is manufactured by Vizaramed, Inc..
What is the FDA product code for Multiflex Steerable Sheath 17.5F?
The FDA product code for Multiflex Steerable Sheath 17.5F 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.