Cleared Special

14Fr Low Profile Introducer Kit

K252766 · Abiomed, Inc. · Cardiovascular
Oct 2025
Decision
40d
Days
Class 2
Risk

About This 510(k) Submission

K252766 is an FDA 510(k) clearance for the 14Fr Low Profile Introducer Kit, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on October 8, 2025, 40 days after receiving the submission on August 29, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K252766 FDA.gov
FDA Decision Cleared SESE
Date Received August 29, 2025
Decision Date October 08, 2025
Days to Decision 40 days
Submission Type Special
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