Sapphire II PRO

Catheters, Transluminal Coronary Angioplasty, Percutaneous

OrbusNeich Medical Trading Inc.

The following data is part of a premarket notification filed by Orbusneich Medical Trading Inc. with the FDA for Sapphire Ii Pro.

Pre-market Notification Details

Device IDK200269
510k NumberK200269
Device Name:Sapphire II PRO
ClassificationCatheters, Transluminal Coronary Angioplasty, Percutaneous
Applicant OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale,  FL  33309
ContactJohn Pazienza
CorrespondentJohn Pazienza
OrbusNeich Medical Trading Inc. 5363 NW 35th Avenue Fort Lauderdale,  FL  33309
Product CodeLOX  
CFR Regulation Number870.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-02-04
Decision Date2020-03-04

© 2020 FDA.report
This site is not affiliated with or endorsed by the FDA.