Submission Details
| 510(k) Number | K242092 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 17, 2024 |
| Decision Date | November 18, 2024 |
| Days to Decision | 124 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
MICRO Arterial Filters
Nov 2024
Decision
124d
Days
Class 2
Risk
About This 510(k) Submission
K242092 is an FDA 510(k) clearance for the MICRO 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 November 18, 2024, 124 days after receiving the submission on July 17, 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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