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FDA 510(k) Applications Submitted by John D. 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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