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 a medical device manufactured by Sorin Group Italia S.R.L.. It received FDA 510(k) clearance on 2024-12-20 under approval 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. It is manufactured by Sorin Group Italia S.R.L.. The 510(k) number is K242953.
When was KIDS Arterial Filters approved by the FDA?
KIDS Arterial Filters received FDA 510(k) clearance on 2024-12-20, under approval number K242953.
What company makes KIDS Arterial Filters?
KIDS Arterial Filters is manufactured by Sorin Group Italia S.R.L..
What is the FDA product code for KIDS Arterial Filters?
The FDA product code for KIDS Arterial Filters is DTM.
Other Devices by Sorin Group Italia S.R.L.
K162215Aortic Arch Cannulae, Optiflow Aortic Arch Cannulae
K161733INSPIRE SVR 1200, INSPIRE 6F C, INSPIRE 8F C
K180979PureFlex Arterial Cannulae
K180411MEMO 4D
K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter
K190650Revolution Centrifugal Blood Pump
Related Devices (Code: DTM)
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.