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D731 Micro 20 Ph.I.S.I.O Pediatric Arterial Filter, D733 Micro 40 Ph.I.S.I.O Pediatric Arterial Filter

by Dideco S.R.L.

510(k) K051232

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 · Special NumberK051232 Date20 May 2005ClearedStatusActive

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  • Withdrawn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)

Full name
D731 Micro 20 Ph.i.s.i.o Pediatric Arterial Filter, D733 Micro 40 Ph.i.si.o Pediatric Arterial Filter
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, 1 Oct 2026

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

The D731 Micro 20 Ph.I.S.I.O Pediatric Arterial Filter and D733 Micro 40 Ph.I.S.I.O Pediatric Arterial Filter are arterial line filters designed for cardiopulmonary bypass circuits. These devices are classified as blood filters and are intended to remove gaseous emboli, aggregated blood constituents, and particulate debris from the arterial line perfusate during pediatric procedures. The D731 features a 20-micron filter screen, while the D733 incorporates a 40-micron screen, both with a phosphorylcholine coating to enhance biocompatibility.

These filters are single-use devices intended for use in the arterial line of extracorporeal circuits during cardiopulmonary bypass procedures. They are supplied sterile and are regulated under FDA 510(k) clearance (K051232) as Class II medical devices. The filters are designed for pediatric applications and must be stored in accordance with manufacturer instructions to maintain sterility and functionality. No MRI safety information is specified for these devices.

Other devices from Dideco S.R.L.

Questions

AI-generated answers, 1 Oct 2026

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

  • What are the D731 and D733 Micro Ph.I.S.I.O Pediatric Arterial Filters designed for?

    These filters are specifically designed for pediatric cardiopulmonary bypass circuits. They are placed in the arterial line to remove gaseous emboli, aggregated blood components, and particulate debris from the perfusate, ensuring safer circulation during pediatric surgical procedures.

  • How do the D731 and D733 differ in filtration capability?

    The D731 features a 20-micron filter screen, providing finer filtration to capture smaller particles, while the D733 uses a 40-micron screen for slightly larger debris. Both are coated with phosphorylcholine to enhance biocompatibility, reducing the risk of clotting or adverse reactions.

  • Are these filters reusable or single-use?

    These are single-use devices only. They are supplied sterile and intended for one-time use in pediatric extracorporeal circuits. Reuse is not recommended as it could compromise sterility and filtration integrity.

  • What storage instructions should be followed to maintain sterility?

    The filters must be stored in their original packaging, sealed and unopened, in a clean, dry environment away from direct sunlight or extreme temperatures. Follow the manufacturer’s instructions to ensure sterility and functionality are preserved until use.

  • Are there any special handling requirements for these filters?

    Since these are sterile, single-use devices, they should only be handled with sterile gloves. Avoid exposing the filter to contaminants or moisture before use. Additionally, ensure compatibility with the pediatric cardiopulmonary bypass circuit system before installation.