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)

FDA 510(k) K172071 · Terumo Cardiovascular Systems Corporation

Substantially Equivalent

510(k) numberK172071

Submission

Device name
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)
Applicant
Terumo Cardiovascular Systems Corporation
Elkton, MD, US
Received
July 10, 2017
Decision date
March 29, 2018
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DTZ – Oxygenator, Cardiopulmonary Bypass
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4350
Specialty
Cardiovascular
Life-sustaining
Yes

Other 510(k)s with product code DTZ

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K253838Lifemotion Disposable Membrane OxygenatorDTZ · Traditional Lifemotion Medical Technology Co., Ltd.03/16/2026SE
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K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR)…DTZ · Traditional Eurosets S.R.L12/12/2025SE
K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)DTZ · Traditional Eurosets S.R.L11/24/2025SE
K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2DTZ · Traditional Qura S.R.L09/12/2024SE
K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface…DTZ · Traditional Medtronic Perfusion Systems07/10/2024SE
K241352Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT…DTZ · Special Medtronic, Inc.06/12/2024SE
K231652D100 Kids; D101 KidsDTZ · Special Sorin Group Italia S.R.L.11/16/2023SE
K231773Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum…DTZ · Traditional Qura S.R.L11/08/2023SE
K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)DTZ · Traditional Chalice Medical , Ltd.11/01/2023SE

More from Chalice Medical , Ltd.

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K234065CDI OneView Monitoring SystemDRY · Traditional 04/25/2024SE
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K200091Capiox iCP Centrifugal PumpKFM · Traditional 11/18/2021SE
K182110CDI Blood Parameter Monitoring System 550DRY · Traditional 11/02/2018SE
K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19…DTZ · Traditional 06/22/2018SE
K172220Advanced Perfusion System 1DTQ · Special 08/17/2017SE
K163531Advanced Perfusion System 1DTQ · Traditional 06/07/2017SE
K162843Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special 11/17/2016SE
K160206VirtuoSaph Plus Endoscopic Vessel Harvesting SystemGEI · Traditional 04/21/2016SE
K153376Advanced Perfusion System 1DTQ · Special 12/16/2015SE

Questions and answers

When was 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) cleared by the FDA?

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) (K172071) received a 510(k) decision of Substantially Equivalent on March 29, 2018, 262 days after the submission was received.

What is the product code of K172071?

The FDA product code is DTZ – Oxygenator, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4350.