Membrane Oxygenator

FDA 510(k) K882892 · Baxter Bentley Laboratories, Inc.

Substantially Equivalent

510(k) numberK882892

Submission

Device name
Membrane Oxygenator
Applicant
Baxter Bentley Laboratories, Inc.
Irvine, CA, US
Received
July 11, 1988
Decision date
September 27, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

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

510(k)DeviceApplicantDecision
K253838Lifemotion Disposable Membrane OxygenatorDTZ · Traditional Lifemotion Medical Technology Co., Ltd.03/16/2026SE
K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood…DTZ · Traditional Spectrum Medical S.R.L.03/12/2026SE
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.

510(k)DeviceDecision
K905312Duraflo II Heparin Treated Femoral Cannulae ModelsDWF · Traditional 01/15/1991SE
K905311Duraflo II Heparin Treated Suction Wands Var. Mod.DWD · Traditional 01/15/1991SE

Questions and answers

When was Membrane Oxygenator cleared by the FDA?

Membrane Oxygenator (K882892) received a 510(k) decision of Substantially Equivalent on September 27, 1988, 78 days after the submission was received.

What is the product code of K882892?

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