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FDA 510(k)

AMG PMP Infant

K-Number: K202510 · 2021-12-10

ApplicantEurosets S.R.L
Decision Date2021-12-10
Product CodeDTZ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMG PMP Infant is a medical device manufactured by Eurosets S.R.L. It received FDA 510(k) clearance on 2021-12-10 under approval number K202510. 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 AMG PMP Infant?

AMG PMP Infant is a medical device that received FDA 510(k) clearance on 2021-12-10. It is manufactured by Eurosets S.R.L. The 510(k) number is K202510.

When was AMG PMP Infant approved by the FDA?

AMG PMP Infant received FDA 510(k) clearance on 2021-12-10, under approval number K202510.

What company makes AMG PMP Infant?

AMG PMP Infant is manufactured by Eurosets S.R.L.

What is the FDA product code for AMG PMP Infant?

The FDA product code for AMG PMP Infant is DTZ.

Other Devices by Eurosets S.R.L

K202206AMG PMP Pediatric 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) K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)

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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