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D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED

K072308 Class II Special
Decision Date
2007-09-12
Sponsor / Applicant
Sorin Group Italia S.R.L.

Technical Specification

510(k) Submission ID K072308
Product Code DTM
Medical Specialty / Panel Cardiovascular
Regulation Citation 21 CFR 870.4260
Decision Date 2007-09-12
Clearance Pathway Special

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

D131 PH.I.S.I.O DIDECO KIDS INFANT ARTERIAL FILTER WITH 40 MICRON SCREEN PHOSPHORYCHOLINE COATED received FDA 510(k) clearance under submission number K072308, sponsored by Sorin Group Italia S.R.L.. The device was reviewed via the Special premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 2007-09-12.

Classification & Regulation

This clearance is catalogued under FDA product code DTM and 21 CFR 870.4260, within the Cardiovascular review panel as a Class II device.