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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 the device name listed in this FDA 510(k) record. The listed applicant is Chalice Medical , Ltd.. It received FDA 510(k) clearance on 2020-09-18 under 510(k) 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. The listed applicant is Chalice Medical , Ltd.. The 510(k) number is K201642.

When did Paragon Adult Maxi PMP Oxygenator with Tubing Pack receive FDA 510(k) clearance?

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

Who is the listed applicant for Paragon Adult Maxi PMP Oxygenator with Tubing Pack?

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 Paragon Adult Maxi PMP Oxygenator with Tubing Pack?

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

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