Cleared Traditional

Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)

K180950 · Terumo Cardiovascular Systems Corporation · Cardiovascular
Jun 2018
Decision
72d
Days
Class 2
Risk

About This 510(k) Submission

K180950 is an FDA 510(k) clearance for the Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation), a Oxygenator, Cardiopulmonary Bypass (Class II — Special Controls, product code DTZ), submitted by Terumo Cardiovascular Systems Corporation (Elkton, US). The FDA issued a Cleared decision on June 22, 2018, 72 days after receiving the submission on April 11, 2018. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4350.

Submission Details

510(k) Number K180950 FDA.gov
FDA Decision Cleared SESE
Date Received April 11, 2018
Decision Date June 22, 2018
Days to Decision 72 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DTZ — Oxygenator, Cardiopulmonary Bypass
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.4350

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