Introducer Sheath Set
K-Number: K254248 · 2026-04-23
Decision Date2026-04-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Introducer Sheath Set is a medical device manufactured by Cardiocycle Medical(Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-23 under approval number K254248. 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 Introducer Sheath Set?
Introducer Sheath Set is a medical device that received FDA 510(k) clearance on 2026-04-23. It is manufactured by Cardiocycle Medical(Suzhou) Co., Ltd.. The 510(k) number is K254248.
When was Introducer Sheath Set approved by the FDA?
Introducer Sheath Set received FDA 510(k) clearance on 2026-04-23, under approval number K254248.
What company makes Introducer Sheath Set?
Introducer Sheath Set is manufactured by Cardiocycle Medical(Suzhou) Co., Ltd..
What is the FDA product code for Introducer Sheath Set?
The FDA product code for Introducer Sheath Set is DYB.
Other Devices by Cardiocycle Medical(Suzhou) Co., Ltd.
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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.