DeviceClearance

AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE— 510(k) K100646

Substantially Equivalent

Medtronic, Inc.

FDA 510(k) clearance K100646 for AFFINITY PIXIE ARTERIAL FILTER WITH BALANCE BIOSURFACE, Substantially Equivalent on 2010-12-16. Applicant: Medtronic, Inc..

Clearance details

Applicant
Medtronic, Inc.
Product code
Code DTM
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Minneapolis, MN, US
Download summary PDFView on FDA.gov ↗

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