Cleared Traditional

IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM

K063723 · Abiomed, Inc. · Cardiovascular
May 2008
Decision
532d
Days
Class 2
Risk

About This 510(k) Submission

K063723 is an FDA 510(k) clearance for the IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM, 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 May 30, 2008, 532 days after receiving the submission on December 15, 2006. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4360.

Submission Details

510(k) Number K063723 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2006
Decision Date May 30, 2008
Days to Decision 532 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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