KIDS Arterial Filters— 510(k) K242953

Substantially Equivalent

Sorin 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..

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code DTM
Advisory panel: Cardiovascular
Date received: 2024-09-25
Decision date: 2024-12-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Mirandola (Modena), IT

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.