Cleared Special

SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM

K021830 · Cobe Cardiovascular, Inc. · Cardiovascular
Jul 2002
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K021830 is an FDA 510(k) clearance for the SORIN BIOMEDICA SMARXT BCD VANGUARD SURFACE MODIFIED CARDIOPLEGIA SYSTEM, a Heat-exchanger, Cardiopulmonary Bypass (Class II — Special Controls, product code DTR), submitted by Cobe Cardiovascular, Inc. (Arvada, US). The FDA issued a Cleared decision on July 2, 2002, 28 days after receiving the submission on June 4, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4240.

Submission Details

510(k) Number K021830 FDA.gov
FDA Decision Cleared SESE
Date Received June 04, 2002
Decision Date July 02, 2002
Days to Decision 28 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTR — Heat-exchanger, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4240

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