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FDA 510(k)

Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)

K-Number: K191246 · 2020-02-28

ApplicantChalice Medical , Ltd.
Decision Date2020-02-28
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) is a medical device manufactured by Chalice Medical , Ltd.. It received FDA 510(k) clearance on 2020-02-28 under approval number K191246. 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 (Model: XCMOP405PMP)?

Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) is a medical device that received FDA 510(k) clearance on 2020-02-28. It is manufactured by Chalice Medical , Ltd.. The 510(k) number is K191246.

When was Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) approved by the FDA?

Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) received FDA 510(k) clearance on 2020-02-28, under approval number K191246.

What company makes Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)?

Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) is manufactured by Chalice Medical , Ltd..

What is the FDA product code for Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)?

The FDA product code for Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP) 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 NCT07495345 Feasibility Study of a Novel Automated Slit Lamp Camera (Lightfield Medical Ophthalmic Camera Model Vscan001) COMPLETED

Other Devices by Chalice Medical , Ltd.

K201642Paragon Adult Maxi PMP Oxygenator with Tubing Pack K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)

Related Devices (Code: DTZ)

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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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