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FDA 510(k)

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

K-Number: K231414 · 2023-11-01

ApplicantChalice Medical , Ltd.
Decision Date2023-11-01
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) is a medical device manufactured by Chalice Medical , Ltd.. It received FDA 510(k) clearance on 2023-11-01 under approval number K231414. The device is classified under product code DTZ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)?

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) is a medical device that received FDA 510(k) clearance on 2023-11-01. It is manufactured by Chalice Medical , Ltd.. The 510(k) number is K231414.

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

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) received FDA 510(k) clearance on 2023-11-01, under approval number K231414.

What company makes CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)?

CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) is manufactured by Chalice Medical , Ltd..

What is the FDA product code for CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)?

The FDA product code for CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) is DTZ.

Related Clinical Trials

NCT07604662 Real-Time Acute Kidney Injury Perioperative Prediction Clinical Trial NOT_YET_RECRUITING NCT06969560 WeRoaM: Wearable Remote Monitoring in Heart Failure RECRUITING NCT06534073 Baropodometric Patterns Associated With Metatarsalgia ACTIVE_NOT_RECRUITING NCT07367620 Immediate Mechanical Complications After Central Venous Catheterization COMPLETED NCT07337577 Large Language Model-Generated Messages to Improve Guideline-Directed Medical Therapy in Heart Failure NOT_YET_RECRUITING NCT05588011 Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass COMPLETED

Other Devices by Chalice Medical , Ltd.

K201642Paragon Adult Maxi PMP Oxygenator with Tubing Pack K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)

Related Devices (Code: DTZ)

K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium BiosurfaceMedtronic, Inc. K162016Affinity NT Oxygenator with Cortiva BioActive SurfaceMedtronic, Inc. K153295TandemLung OxygenatorCardiacassist, Inc. K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive SurfaceMedtronic, Inc. K172626Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Fusion Oxygenator with Cortiva Biosurface, Affinity Fusion Oxygenator with Cortiva BioActive Surface & Cardiotomy/Venous ReservoirMedtronic, Inc. K180950Terumo 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)Terumo Cardiovascular Systems Corporation

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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