Micropuncture Introducer Sets; Micropuncture Pedal Access Sets
K-Number: K240589 · 2024-03-25
ApplicantCook Medical
Decision Date2024-03-25
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Micropuncture Introducer Sets; Micropuncture Pedal Access Sets is a medical device manufactured by Cook Medical. It received FDA 510(k) clearance on 2024-03-25 under approval number K240589. 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 Micropuncture Introducer Sets; Micropuncture Pedal Access Sets?
Micropuncture Introducer Sets; Micropuncture Pedal Access Sets is a medical device that received FDA 510(k) clearance on 2024-03-25. It is manufactured by Cook Medical. The 510(k) number is K240589.
When was Micropuncture Introducer Sets; Micropuncture Pedal Access Sets approved by the FDA?
Micropuncture Introducer Sets; Micropuncture Pedal Access Sets received FDA 510(k) clearance on 2024-03-25, under approval number K240589.
What company makes Micropuncture Introducer Sets; Micropuncture Pedal Access Sets?
Micropuncture Introducer Sets; Micropuncture Pedal Access Sets is manufactured by Cook Medical.
What is the FDA product code for Micropuncture Introducer Sets; Micropuncture Pedal Access Sets?
The FDA product code for Micropuncture Introducer Sets; Micropuncture Pedal Access Sets 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.