CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)

FDA 510(k) K231414 · Chalice Medical , Ltd.

Substantially Equivalent

510(k) numberK231414

Submission

Device name
CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
Applicant
Chalice Medical , Ltd.
Worksop, GB
Received
May 16, 2023
Decision date
November 1, 2023
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

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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
K230640Affinity Fusion™ Oxygenator SystemDTZ · Special Medtronic, Inc.04/06/2023SE

More from Medtronic, Inc.

510(k)DeviceDecision
K201642Paragon Adult Maxi PMP Oxygenator with Tubing PackDTZ · Traditional 09/18/2020SE
K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)DTZ · Traditional 02/28/2020SE

Questions and answers

When was CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) cleared by the FDA?

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) (K231414) received a 510(k) decision of Substantially Equivalent on November 1, 2023, 169 days after the submission was received.

What is the product code of K231414?

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