Cleared Special

TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT

K021287 · Medtronic Perfusion Systems · Cardiovascular
May 2002
Decision
14d
Days
Class 2
Risk

About This 510(k) Submission

K021287 is an FDA 510(k) clearance for the TRILLIUM AFFINITY NT CARDIOTOMY VENOUS RESERVOIR, MODELS 540T, 541TT, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Medtronic Perfusion Systems (Minneapolis, US). The FDA issued a Cleared decision on May 7, 2002, 14 days after receiving the submission on April 23, 2002. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number K021287 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2002
Decision Date May 07, 2002
Days to Decision 14 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTN — Reservoir, Blood, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4400

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