Prelude IDeal 9F Hydrophilic Sheath Introducer
K-Number: K212152 · 2022-01-07
ApplicantMerit Medical Systems
Decision Date2022-01-07
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Prelude IDeal 9F Hydrophilic Sheath Introducer is a medical device manufactured by Merit Medical Systems. It received FDA 510(k) clearance on 2022-01-07 under approval number K212152. 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 IDeal 9F Hydrophilic Sheath Introducer?
Prelude IDeal 9F Hydrophilic Sheath Introducer is a medical device that received FDA 510(k) clearance on 2022-01-07. It is manufactured by Merit Medical Systems. The 510(k) number is K212152.
When was Prelude IDeal 9F Hydrophilic Sheath Introducer approved by the FDA?
Prelude IDeal 9F Hydrophilic Sheath Introducer received FDA 510(k) clearance on 2022-01-07, under approval number K212152.
What company makes Prelude IDeal 9F Hydrophilic Sheath Introducer?
Prelude IDeal 9F Hydrophilic Sheath Introducer is manufactured by Merit Medical Systems.
What is the FDA product code for Prelude IDeal 9F Hydrophilic Sheath Introducer?
The FDA product code for Prelude IDeal 9F Hydrophilic Sheath Introducer 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.