AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE— 510(k) K122760

Name: FDA 510(k) clearance K122760
Creator: U.S. Food and Drug Administration
Published: 2012-12-07

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K122760 for AFFINITY AF100 ARTERIAL FILTER WITH BALANCE BIOSURFACE, Substantially Equivalent on 2012-12-07. Applicant: Medtronic, Inc.. Device class: 2.

Clearance details

Applicant: Medtronic, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 2012-09-10
Decision date: 2012-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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