Performer Guiding Sheath
K-Number: K171988 · 2018-03-30
ApplicantCook Incorporated
Decision Date2018-03-30
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Performer Guiding Sheath is a medical device manufactured by Cook Incorporated. It received FDA 510(k) clearance on 2018-03-30 under approval number K171988. 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 Performer Guiding Sheath?
Performer Guiding Sheath is a medical device that received FDA 510(k) clearance on 2018-03-30. It is manufactured by Cook Incorporated. The 510(k) number is K171988.
When was Performer Guiding Sheath approved by the FDA?
Performer Guiding Sheath received FDA 510(k) clearance on 2018-03-30, under approval number K171988.
What company makes Performer Guiding Sheath?
Performer Guiding Sheath is manufactured by Cook Incorporated.
What is the FDA product code for Performer Guiding Sheath?
The FDA product code for Performer Guiding 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.