Cleared Traditional

Impella CP Introducer

K192769 · Abiomed, Inc. · Cardiovascular
Nov 2019
Decision
49d
Days
Class 2
Risk

About This 510(k) Submission

K192769 is an FDA 510(k) clearance for the Impella CP Introducer, a Introducer, Catheter (Class II — Special Controls, product code DYB), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on November 18, 2019, 49 days after receiving the submission on September 30, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1340.

Submission Details

510(k) Number K192769 FDA.gov
FDA Decision Cleared SESE
Date Received September 30, 2019
Decision Date November 18, 2019
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