Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

KIDS Arterial Filters

K-Number: K242953 · 2024-12-20

ApplicantSorin Group Italia S.R.L.
Decision Date2024-12-20
Product CodeDTM
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

KIDS 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 2024-12-20 under 510(k) number K242953. 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 KIDS Arterial Filters?

KIDS Arterial Filters is a medical device that received FDA 510(k) clearance on 2024-12-20. The listed applicant is Sorin Group Italia S.R.L.. The 510(k) number is K242953.

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

KIDS Arterial Filters received FDA 510(k) clearance on 2024-12-20, under 510(k) number K242953.

Who is the listed applicant for KIDS 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 KIDS Arterial Filters?

The FDA product code for KIDS Arterial Filters is DTM.

Other records listing Sorin Group Italia S.R.L. 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.

K253671Dual Stage Venous CannulaeK251783Inspire HCR and HCR DUAL cardiotomy reservoirsK253616ProtekDilate Vascular Access KitK250610Easyflow (103-200; 103-300); Easyflow Duo (103-210; 103-310)K250150VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)K243264DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemoconcentrator (SH 14)

View all 24 devices →

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 FilterMedtronicK242092MICRO 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.

↑