AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS— 510(k) K093986

Name: FDA 510(k) clearance K093986
Creator: U.S. Food and Drug Administration
Published: 2010-01-22

Substantially Equivalent

Sorin Group Italia S.R.L.

FDA 510(k) clearance K093986 for AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS, Substantially Equivalent on 2010-01-22. Applicant: Sorin Group Italia S.R.L.. Device class: 2.

Clearance details

Applicant: Sorin Group Italia S.R.L.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2009-12-24
Decision date: 2010-01-22
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.