Guide Sheath
K-Number: K190644 · 2019-04-18
ApplicantSurmodics,Inc.
Decision Date2019-04-18
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Guide Sheath is a medical device manufactured by Surmodics,Inc.. It received FDA 510(k) clearance on 2019-04-18 under approval number K190644. 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 Guide Sheath?
Guide Sheath is a medical device that received FDA 510(k) clearance on 2019-04-18. It is manufactured by Surmodics,Inc.. The 510(k) number is K190644.
When was Guide Sheath approved by the FDA?
Guide Sheath received FDA 510(k) clearance on 2019-04-18, under approval number K190644.
What company makes Guide Sheath?
Guide Sheath is manufactured by Surmodics,Inc..
What is the FDA product code for Guide Sheath?
The FDA product code for Guide 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.