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 a medical device manufactured by Cultiv8 1, LLC. It received FDA 510(k) clearance on 2026-01-22 under approval 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. It is manufactured by Cultiv8 1, LLC. The 510(k) number is K253652.
When was Genie MAX Large Bore Introducer Sheath approved by the FDA?
Genie MAX Large Bore Introducer Sheath received FDA 510(k) clearance on 2026-01-22, under approval number K253652.
What company makes Genie MAX Large Bore Introducer Sheath?
Genie MAX Large Bore Introducer Sheath is manufactured by Cultiv8 1, LLC.
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 Devices (Code: DYB)
K162322the POWERWAND Safety Introducer with an Extended Dwell Catheter, 3Fr. ModelAccess Scientific, LLC
K162097InTRAkitMedtronic Vascular
K162769Pinpoint GT Introducer NeedleC.R. Bard, Inc.
K153771TXM Guiding SheathTexasmedical Technologies, Inc.
K162184Edwards eSheath Introducer SetEdward Lifesciences
K153494HQS Introducer (Model 2064-HQS)Alseal
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.