Cleared Traditional

LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST

K131618 · Terumo Cardiovascular Systems Corporation · Cardiovascular
Sep 2013
Decision
116d
Days
Class 2
Risk

About This 510(k) Submission

K131618 is an FDA 510(k) clearance for the LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYSTEM 1; LARGE (6) ROLLER PUMP FOR TERUMO ADVANCED PERFUSION SYST, a Pump, Blood, Cardiopulmonary Bypass, Roller Type (Class II — Special Controls, product code DWB), submitted by Terumo Cardiovascular Systems Corporation (Ann Arbor, US). The FDA issued a Cleared decision on September 27, 2013, 116 days after receiving the submission on June 3, 2013. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4370.

Submission Details

510(k) Number K131618 FDA.gov
FDA Decision Cleared SESE
Date Received June 03, 2013
Decision Date September 27, 2013
Days to Decision 116 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DWB — Pump, Blood, Cardiopulmonary Bypass, Roller Type
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4370

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