Cleared Traditional

Abiomed 14Fr Low Profile Introducer Set

K222113 · Abiomed, Inc. · Cardiovascular
Oct 2022
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K222113 is an FDA 510(k) clearance for the Abiomed 14Fr Low Profile Introducer Set, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on October 13, 2022, 87 days after receiving the submission on July 18, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K222113 FDA.gov
FDA Decision Cleared SESE
Date Received July 18, 2022
Decision Date October 13, 2022
Days to Decision 87 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