Cleared Traditional

Genie MAX Large Bore Introducer Sheath

K253652 · Cultiv8 1, LLC · Cardiovascular
Jan 2026
Decision
63d
Days
Class 2
Risk

About This 510(k) Submission

K253652 is an FDA 510(k) clearance for the Genie MAX Large Bore Introducer Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Cultiv8 1, LLC (Plymouth, US). The FDA issued a Cleared decision on January 22, 2026, 63 days after receiving the submission on November 20, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K253652 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 2025
Decision Date January 22, 2026
Days to Decision 63 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DYB — Introducer, Catheter
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1340