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FDA 510(k)

Introducer Sheath Set

K-Number: K254248 · 2026-04-23

ApplicantCardiocycle Medical(Suzhou) Co., Ltd.
Decision Date2026-04-23
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Introducer Sheath Set is the device name listed in this FDA 510(k) record. The listed applicant is Cardiocycle Medical(Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2026-04-23 under 510(k) 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. The listed applicant is Cardiocycle Medical(Suzhou) Co., Ltd.. The 510(k) number is K254248.

When did Introducer Sheath Set receive FDA 510(k) clearance?

Introducer Sheath Set received FDA 510(k) clearance on 2026-04-23, under 510(k) number K254248.

Who is the listed applicant for Introducer Sheath Set?

The FDA 510(k) record lists Cardiocycle Medical(Suzhou) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Introducer Sheath Set?

The FDA product code for Introducer Sheath Set is DYB.

Other records listing Cardiocycle Medical(Suzhou) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251838Introducer Sheath Set

Related Devices (Code: DYB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253526NAMIC Dilator and SheathMedline Industries, LPK261529Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set/ Microintroducer Kit / Microintroducer Kit (SIS05C); Micropuncture Kit / Micropuncture Access Kit / Micropuncture Introducer Set / Microintroducer Kit / Microintroducer Kit (IS01); Introducer Kit / Microintroducer Kit / Introducer Set /Microintroducer Set / Micro Introducer Sheath Set / Introducer Sheath Set (NIS04)Hartman Medical Group, LLCK261242SimplGuidePendracareK261950Health Line Tearaway IntroducerHealth Line International CorporationK261492FieldFlex Steerable SheathCenterPoint Systems, LLCK260606Echo Large Bore Introducer SheathEcho Medical, LLC

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.

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