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D130 Ph.i.s.i.o Dideco Kids Neonatal Arterial Filter With 40 Micron Screen Phosphorylcholine Coated

by Sorin Group Italia S.R.L.

510(k) K063255

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK063255 Date11 Jan 2007ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DTM
Device Class
Class II
Regulation
21 CFR Part 870.4260
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 21 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The D130 Ph.i.s.i.o Dideco Kids is a neonatal and infant arterial filter designed for use in cardiopulmonary bypass circuits. It features a 40 micron screen to permit the separation of gaseous emboli from the blood during perfusion.

This device is supplied with a phosphorylcholine-coated surface to provide biocompatibility. It is regulated under FDA 510(k) clearance and is intended for use with a suitable purge line for the removal of air.

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