Cleared Traditional

IMPELLA 5.0 CATHETER FAMILY

K083111 · Abiomed, Inc. · Cardiovascular
Apr 2009
Decision
177d
Days
Class 2
Risk

About This 510(k) Submission

K083111 is an FDA 510(k) clearance for the IMPELLA 5.0 CATHETER FAMILY, a Pump, Blood, Cardiopulmonary Bypass, Non-roller Type (Class II — Special Controls, product code KFM), submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on April 16, 2009, 177 days after receiving the submission on October 21, 2008. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.

Submission Details

510(k) Number K083111 FDA.gov
FDA Decision Cleared SESE
Date Received October 21, 2008
Decision Date April 16, 2009
Days to Decision 177 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code KFM — Pump, Blood, Cardiopulmonary Bypass, Non-roller Type
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4360

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