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FDA 510(k)

Paragon Adult Maxi PMP Oxygenator with Tubing Pack

K-Number: K201642 · 2020-09-18

ApplicantChalice Medical , Ltd.
Decision Date2020-09-18
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Paragon Adult Maxi PMP Oxygenator with Tubing Pack is a medical device manufactured by Chalice Medical , Ltd.. It received FDA 510(k) clearance on 2020-09-18 under approval number K201642. 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 Paragon Adult Maxi PMP Oxygenator with Tubing Pack?

Paragon Adult Maxi PMP Oxygenator with Tubing Pack is a medical device that received FDA 510(k) clearance on 2020-09-18. It is manufactured by Chalice Medical , Ltd.. The 510(k) number is K201642.

When was Paragon Adult Maxi PMP Oxygenator with Tubing Pack approved by the FDA?

Paragon Adult Maxi PMP Oxygenator with Tubing Pack received FDA 510(k) clearance on 2020-09-18, under approval number K201642.

What company makes Paragon Adult Maxi PMP Oxygenator with Tubing Pack?

Paragon Adult Maxi PMP Oxygenator with Tubing Pack is manufactured by Chalice Medical , Ltd..

What is the FDA product code for Paragon Adult Maxi PMP Oxygenator with Tubing Pack?

The FDA product code for Paragon Adult Maxi PMP Oxygenator with Tubing Pack is DTZ.

Related Clinical Trials

NCT05588011 Influence of Oxygenator Selection on Platelet Function and Rotational Thromboelastometry Following Cardiopulmonary Bypass COMPLETED

Other Devices by Chalice Medical , Ltd.

K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)

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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