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FDA 510(k) Applications Submitted by Monika McDole-Russell
FDA 510(k) Number
Submission Date
Device Name
Applicant
K150232
02/02/2015
Radifocus Optitorque Angiographic Catheter
ASHITAKA FACTORY OF TERUMO CORP.
K170417
02/10/2017
Glidewire GT
Terumo Corporation
K131276
05/06/2013
LATERAL SYNFIX
SYNTHES (USA) PRODUCTS LLC
K121852
06/25/2012
SYNTHES ZERO-P VARIABLE ANGLE (VA)
SYNTHES SPINE CO.LP
K152498
09/01/2015
SoloPath Re-Collapsible Access System
ONSET MEDICAL CORPORATION
K123180
10/10/2012
FALCON SPACER
SYNTHES (USA) PRODUCTS LLC
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