Cleared Traditional

STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05

K103469 · Sorin Group Deutschland GmbH · Cardiovascular

Jan 2011

Decision

55d

Days

Class 2

Risk

About This 510(k) Submission

K103469 is an FDA 510(k) clearance for the STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05, a Detector, Bubble, Cardiopulmonary Bypass (Class II — Special Controls, product code KRL), submitted by Sorin Group Deutschland GmbH (North Attleboro, US). The FDA issued a Cleared decision on January 18, 2011, 55 days after receiving the submission on November 24, 2010. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4205.

Submission Details

510(k) Number	K103469 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 24, 2010
Decision Date	January 18, 2011
Days to Decision	55 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF