Cleared Traditional

IMPELLA CONTROLLER

K093801 · Abiomed, Inc. · Cardiovascular
Jul 2010
Decision
210d
Days
Class 2
Risk

About This 510(k) Submission

K093801 is an FDA 510(k) clearance for the IMPELLA CONTROLLER, 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 July 8, 2010, 210 days after receiving the submission on December 10, 2009. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.

Submission Details

510(k) Number K093801 FDA.gov
FDA Decision Cleared SESE
Date Received December 10, 2009
Decision Date July 08, 2010
Days to Decision 210 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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