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FDA 510(k)

Genie MAX Large Bore Introducer Sheath

K-Number: K253652 · 2026-01-22

ApplicantCultiv8 1, LLC
Decision Date2026-01-22
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Genie MAX Large Bore Introducer Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Cultiv8 1, LLC. It received FDA 510(k) clearance on 2026-01-22 under 510(k) number K253652. 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 Genie MAX Large Bore Introducer Sheath?

Genie MAX Large Bore Introducer Sheath is a medical device that received FDA 510(k) clearance on 2026-01-22. The listed applicant is Cultiv8 1, LLC. The 510(k) number is K253652.

When did Genie MAX Large Bore Introducer Sheath receive FDA 510(k) clearance?

Genie MAX Large Bore Introducer Sheath received FDA 510(k) clearance on 2026-01-22, under 510(k) number K253652.

Who is the listed applicant for Genie MAX Large Bore Introducer Sheath?

The FDA 510(k) record lists Cultiv8 1, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Genie MAX Large Bore Introducer Sheath?

The FDA product code for Genie MAX Large Bore Introducer Sheath is DYB.

Related Clinical Trials

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.

NCT06851481The Ladera Suture-Mediated Large Bore Closure StudyCOMPLETEDNCT07541235The Ladera Suture-Mediated Large Bore Closure Pivotal StudyNOT_YET_RECRUITINGNCT07743697Comparing Suture vs. Combined Closure Strategies for Large Blood Vessel Access in Patients Undergoing Transcatheter Aortic Valve Implantation (TAVI)NOT_YET_RECRUITING

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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