Cleared Special

SORIN CENTRIFUGAL PUMP 5 (CP5)

K112225 · Sorin Group Deutschland GmbH · Cardiovascular
Sep 2011
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K112225 is an FDA 510(k) clearance for the SORIN CENTRIFUGAL PUMP 5 (CP5), a Control, Pump Speed, Cardiopulmonary Bypass (Class II — Special Controls, product code DWA), submitted by Sorin Group Deutschland GmbH (North Attleboro, US). The FDA issued a Cleared decision on September 20, 2011, 48 days after receiving the submission on August 3, 2011. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number K112225 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2011
Decision Date September 20, 2011
Days to Decision 48 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWA — Control, Pump Speed, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4380

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