Cleared Traditional

Abiomed 23 Fr Sheath

K201116 · Abiomed, Inc. · Cardiovascular
Jun 2020
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K201116 is an FDA 510(k) clearance for the Abiomed 23 Fr Sheath, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on June 15, 2020, 49 days after receiving the submission on April 27, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K201116 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 2020
Decision Date June 15, 2020
Days to Decision 49 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