Prelude Guide Sheath
K-Number: K211405 · 2021-10-04
ApplicantMerit Medical Systems, Inc.
Decision Date2021-10-04
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Prelude Guide Sheath is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2021-10-04 under approval number K211405. 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 Prelude Guide Sheath?
Prelude Guide Sheath is a medical device that received FDA 510(k) clearance on 2021-10-04. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K211405.
When was Prelude Guide Sheath approved by the FDA?
Prelude Guide Sheath received FDA 510(k) clearance on 2021-10-04, under approval number K211405.
What company makes Prelude Guide Sheath?
Prelude Guide Sheath is manufactured by Merit Medical Systems, Inc..
What is the FDA product code for Prelude Guide Sheath?
The FDA product code for Prelude Guide Sheath is DYB.
Related Clinical Trials
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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.