D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER— 510(k) K051232

Name: FDA 510(k) clearance K051232
Creator: U.S. Food and Drug Administration
Published: 2005-05-20

Substantially Equivalent

Dideco S.R.L.

FDA 510(k) clearance K051232 for D731 MICRO 20 PH.I.S.I.O PEDIATRIC ARTERIAL FILTER, D733 MICRO 40 PH.I.SI.O PEDIATRIC ARTERIAL FILTER, Substantially Equivalent on 2005-05-20. Applicant: Dideco S.R.L.. Device class: 2.

Clearance details

Applicant: Dideco S.R.L.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2005-05-13
Decision date: 2005-05-20
Decision: Substantially Equivalent
Clearance type: Special
Location: Waltham, MA, US

Download summary PDF View on FDA.gov ↗

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