Submission Details
| 510(k) Number | K242953 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 25, 2024 |
| Decision Date | December 20, 2024 |
| Days to Decision | 86 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
KIDS Arterial Filters
Dec 2024
Decision
86d
Days
Class 2
Risk
About This 510(k) Submission
K242953 is an FDA 510(k) clearance for the KIDS Arterial Filters, a Filter, Blood, Cardiopulmonary Bypass, Arterial Line (Class II — Special Controls, product code DTM), submitted by Sorin Group Italia S.R.L. (Mirandola (Modena), IT). The FDA issued a Cleared decision on December 20, 2024, 86 days after receiving the submission on September 25, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4260.
Device Classification
| Product Code | DTM — Filter, Blood, Cardiopulmonary Bypass, Arterial Line |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4260 |
Manufacturer
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