Cleared Traditional

Abiomed 14Fr Low Profile Introducer Kit

K241708 · Abiomed, Inc. · Cardiovascular
Aug 2024
Decision
54d
Days
Class 2
Risk

About This 510(k) Submission

K241708 is an FDA 510(k) clearance for the Abiomed 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 August 6, 2024, 54 days after receiving the submission on June 13, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K241708 FDA.gov
FDA Decision Cleared SESE
Date Received June 13, 2024
Decision Date August 06, 2024
Days to Decision 54 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