FDA 510(k) Applications Submitted by Isoray Medical, Inc.

FDA 510(k) Number Submission Date Device Name Applicant
K092136 07/15/2009 PROXCELAN CS-131 PRELOADED BRAIDED STRANDS, MODEL: PL-5 ISORAY MEDICAL, INC.
K092458 08/11/2009 PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 ISORAY MEDICAL, INC.
K111931 07/08/2011 GLIASITE RTS ISORAY MEDICAL, INC.
K202267 08/11/2020 Sirius MRI Markers, Cs-131 Preloaded Strands with Sirius MRI Markers in 18 Gauge Needles Isoray Medical, Inc.


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