Cleared Traditional

STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS)

K103468 · Sorin Group Deutschland GmbH · Cardiovascular
Jan 2011
Decision
57d
Days
Class 2
Risk

About This 510(k) Submission

K103468 is an FDA 510(k) clearance for the STOCKERT CENTRIFUGAL PUMP (SCP PLUS) (COMPLETE) OR (FOR S5/C5 SYSTEMS), 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 January 20, 2011, 57 days after receiving the submission on November 24, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4380.

Submission Details

510(k) Number K103468 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 2010
Decision Date January 20, 2011
Days to Decision 57 days
Submission Type Traditional
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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