Micropuncture Pedal Access Set
K-Number: K172980 · 2018-05-03
ApplicantCook Incorporated
Decision Date2018-05-03
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Micropuncture Pedal Access Set is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-05-03 under approval number K172980. 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 Pedal Access Set?
Micropuncture Pedal Access Set is a medical device that received FDA 510(k) clearance on 2018-05-03. It is manufactured by Cook Incorporated. The 510(k) number is K172980.
When was Micropuncture Pedal Access Set approved by the FDA?
Micropuncture Pedal Access Set received FDA 510(k) clearance on 2018-05-03, under approval number K172980.
What company makes Micropuncture Pedal Access Set?
Micropuncture Pedal Access Set is manufactured by Cook Incorporated.
What is the FDA product code for Micropuncture Pedal Access Set?
The FDA product code for Micropuncture Pedal Access Set 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.