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FDA 510(k)

MICRO Arterial Filters

K-Number: K242092 · 2024-11-18

ApplicantSorin Group Italia S.R.L.
Decision Date2024-11-18
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MICRO Arterial Filters is a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2024-11-18 under approval number K242092. The device is classified under product code DTM. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICRO Arterial Filters?

MICRO Arterial Filters is a medical device that received FDA 510(k) clearance on 2024-11-18. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K242092.

When was MICRO Arterial Filters approved by the FDA?

MICRO Arterial Filters received FDA 510(k) clearance on 2024-11-18, under approval number K242092.

What company makes MICRO Arterial Filters?

MICRO Arterial Filters is manufactured by Sorin Group Italia S.R.L..

What is the FDA product code for MICRO Arterial Filters?

The FDA product code for MICRO Arterial Filters is DTM.

Related Clinical Trials

NCT02748941 Carotid Atherosclerosis : Innovative Imaging Biomarkers. Study Case-control RECRUITING NCT05537389 Intravenous Neonatal Central Access Safety Trial RECRUITING

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Related Devices (Code: DTM)

K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc. K242953KIDS Arterial FiltersSorin Group Italia S.R.L. K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronic

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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