Cleared Traditional

MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711

K031700 · Medtronic Perfusion Systems · Cardiovascular
Aug 2003
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K031700 is an FDA 510(k) clearance for the MEDTRONIC RESTING HEART SYSTEM, MODEL AAR1000 AND 711, 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 August 29, 2003, 88 days after receiving the submission on June 2, 2003. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number K031700 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2003
Decision Date August 29, 2003
Days to Decision 88 days
Submission Type Traditional
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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