Cleared Special

Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface

K170583 · Medtronic, Inc. · Cardiovascular
Mar 2017
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K170583 is an FDA 510(k) clearance for the Intersept Filtered Cardiotomy Reservoir with Cortiva BioActive Surface, a Reservoir, Blood, Cardiopulmonary Bypass (Class II — Special Controls, product code DTN), submitted by Medtronic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on March 17, 2017, 17 days after receiving the submission on February 28, 2017. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4400.

Submission Details

510(k) Number K170583 FDA.gov
FDA Decision Cleared SESE
Date Received February 28, 2017
Decision Date March 17, 2017
Days to Decision 17 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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