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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 the device name listed in this FDA 510(k) record. The listed applicant is Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2024-11-18 under 510(k) 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. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K242092.

When did MICRO Arterial Filters receive FDA 510(k) clearance?

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

Who is the listed applicant for MICRO Arterial Filters?

The FDA 510(k) record lists Sorin Group Italia S.R.L. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRO Arterial Filters?

The FDA product code for MICRO Arterial Filters is DTM.

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Related Devices (Code: DTM)

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.

K251744Affinity Pixie™ Arterial Filter with Balance™ Biosurface; Affinity® Pediatric Arterial Blood FilterMedtronicK242953KIDS Arterial FiltersSorin Group Italia S.R.L.K231362OCS Heart Leukocyte Depleting FilterTransMedics, Inc.

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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