Cleared Traditional

Element Vascular Access System

K242520 · Penumbra, Inc. · Cardiovascular
Nov 2024
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K242520 is an FDA 510(k) clearance for the Element Vascular Access System, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Penumbra, Inc. (Alameda, US). The FDA issued a Cleared decision on November 20, 2024, 89 days after receiving the submission on August 23, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K242520 FDA.gov
FDA Decision Cleared SESE
Date Received August 23, 2024
Decision Date November 20, 2024
Days to Decision 89 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