EXTesia Introducer Sheath Set
K-Number: K220604 · 2022-04-27
ApplicantCuratia Medical Co.
Decision Date2022-04-27
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
EXTesia Introducer Sheath Set is a medical device manufactured by Curatia Medical Co.. It received FDA 510(k) clearance on 2022-04-27 under approval number K220604. 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 EXTesia Introducer Sheath Set?
EXTesia Introducer Sheath Set is a medical device that received FDA 510(k) clearance on 2022-04-27. It is manufactured by Curatia Medical Co.. The 510(k) number is K220604.
When was EXTesia Introducer Sheath Set approved by the FDA?
EXTesia Introducer Sheath Set received FDA 510(k) clearance on 2022-04-27, under approval number K220604.
What company makes EXTesia Introducer Sheath Set?
EXTesia Introducer Sheath Set is manufactured by Curatia Medical Co..
What is the FDA product code for EXTesia Introducer Sheath Set?
The FDA product code for EXTesia Introducer Sheath 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.