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Genie MAX Large Bore Introducer Sheath

by Cultiv8 1, LLC 510(k)

Active United States

510(k) K253652

Overview

The Genie MAX Large Bore Introducer Sheath is a vascular introducer sheath designed to serve as a conduit for intravascular devices. It provides a hemostatic seal to minimize blood loss during procedures, facilitating safe and controlled access to the vasculature.

This device is intended for single-use in clinical settings such as catheterization labs or interventional radiology. Supplied sterile, it includes an introducer sheath, protector, dilator, and a 3cc syringe. The Genie MAX Large Bore Introducer Sheath holds an FDA 510(k) clearance under K253652, classified under product code DYB for vascular introducer sheaths.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK253652 Date22 Jan 2026ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
DYB
Device Class
Class II
Regulation
21 CFR Part 870.1340
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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Questions

  • What clinical settings is the Genie MAX Large Bore Introducer Sheath designed for use in, and why is it considered single-use?

    The Genie MAX Large Bore Introducer Sheath is designed for use in clinical settings like catheterization labs and interventional radiology, where controlled vascular access is critical. It is intended for single-use because it is supplied sterile and includes components like the introducer sheath, protector, dilator, and syringe, which are meant to be discarded after one procedure to maintain sterility and minimize infection risks.

  • What components are included with the Genie MAX Large Bore Introducer Sheath, and how does the hemostatic seal work?

    The Genie MAX Large Bore Introducer Sheath comes with four key components: the introducer sheath itself, a protector (to prevent contamination), a dilator (for initial vessel access), and a 3cc syringe (for flushing or contrast injection). The hemostatic seal is designed to minimize blood loss during procedures by creating a secure barrier around the inserted device, ensuring stable access while reducing leakage.

  • Is the Genie MAX Large Bore Introducer Sheath reusable, and if not, what should be done with it after use?

    No, the Genie MAX Large Bore Introducer Sheath is not reusable—it is explicitly designed for single-use only. After use, the entire assembly (sheath, protector, dilator, and syringe) should be discarded in accordance with medical waste protocols to prevent cross-contamination and maintain sterile field integrity.

  • How is the sterility of the Genie MAX Large Bore Introducer Sheath ensured, and what precautions should be taken during storage?

    The Genie MAX Large Bore Introducer Sheath is supplied sterile as part of its packaging, meaning it is pre-sterilized and sealed to prevent contamination before use. To maintain sterility during storage, it should be kept in its original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid exposing the sheath to moisture or physical damage that could compromise its sterile barrier.

  • What does the FDA 510(k) clearance (K253652) under product code DYB indicate about this device’s regulatory status?

    The FDA 510(k) clearance (K253652) under product code DYB (vascular introducer sheaths) confirms that the Genie MAX Large Bore Introducer Sheath has been determined substantially equivalent to a legally marketed predicate device through a traditional review process by the FDA’s Cardiovascular (CV) advisory committee. This means it meets the agency’s requirements for safety and effectiveness as a vascular introducer sheath, but it does not imply any specific clinical indication—only that it follows established regulatory standards for its category.