FDA 510(k) Applications Submitted by John Pazienza

FDA 510(k) Number Submission Date Device Name Applicant
K200269 02/04/2020 Sapphire II PRO OrbusNeich Medical Trading Inc.
K180921 04/09/2018 Sapphire II PRO Balloon Dilatation Catheter OrbusNeich Medical Trading Inc.
K192344 08/29/2019 Sapphire NC Plus Coronary Dilatation Catheter OrbusNeich Medical Trading Inc.
K182360 08/30/2018 Teleport Microcatheter OrbusNeich Medical Trading Inc.
K182713 09/27/2018 Scoreflex PTA Scoring Balloon Catheter OrbusNeich Medical Trading, Inc.
K163114 11/07/2016 Sapphire II PRO OrbusNeich Medical Inc.
K173680 12/01/2017 Sapphire II PRO OrbusNeich Medical Trading Inc.
K103657 12/15/2010 SAPPHIRE ORBUSNEICH MEDICAL, INC.
K173894 12/21/2017 Jade PTA Balloon Dilatation Catheter OrbusNeich Medical Trading Inc.
K103808 12/29/2010 SAPPHIRE NC ORBUSNEICH MEDICAL, INC.
K162209 08/05/2016 Sapphire NC Plus OrbusNeich Medical, Inc


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