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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 the device name listed in this FDA 510(k) record. The listed applicant is Chalice Medical , Ltd.. It received FDA 510(k) clearance on 2023-11-01 under 510(k) 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. The listed applicant is Chalice Medical , Ltd.. The 510(k) number is K231414.

When did CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009) receive FDA 510(k) clearance?

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

Who is the listed applicant for CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)?

The FDA 510(k) record lists Chalice Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Chalice Medical , Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K201642Paragon Adult Maxi PMP Oxygenator with Tubing PackK191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)

Related Devices (Code: DTZ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253838Lifemotion Disposable Membrane OxygenatorLifemotion Medical Technology Co., Ltd.K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3); Quantum Perfusion Blood Oxygenator VT75- E3 (VT75- E3);Spectrum Medical S.R.L.K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (US5204); Horizon CVR (US5073)Eurosets S.R.LK242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)Eurosets S.R.LK231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2Qura S.R.LK240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator with Integrated Arterial Filter and Cardiotomy/Venous Reservoir with Balance Biosurface (BB841); Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface NON STERILE (BB811-NS)Medtronic Perfusion Systems

Official Source

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

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