KIDS Arterial Filters— 510(k) K242953
Substantially EquivalentSorin Group Italia S.R.L.
FDA 510(k) clearance K242953 for KIDS Arterial Filters, Substantially Equivalent on 2024-12-20. Applicant: Sorin Group Italia S.R.L.. Device class: 2.
Clearance details
- Applicant
- Sorin Group Italia S.R.L.
- Product code
- Code DTM
- Device class
- Class 2
- Regulation
- 21 CFR 870.4260
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Mirandola (Modena), IT
Recent devices under product code DTM
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- K231362 — OCS Heart Leukocyte Depleting Filter
- K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE
- K122760 — AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE
More clearances from Sorin Group Italia S.R.L.
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