Cleared Traditional

Impella XR Sheath Set

K202330 · Abiomed, Inc. · Cardiovascular
Dec 2020
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K202330 is an FDA 510(k) clearance for the Impella XR Sheath Set, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on December 7, 2020, 112 days after receiving the submission on August 17, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K202330 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 2020
Decision Date December 07, 2020
Days to Decision 112 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