AHMED ClearPath Glaucoma Drainage Device

Implant, Eye Valve

New World Medical, Inc.

The following data is part of a premarket notification filed by New World Medical, Inc. with the FDA for Ahmed Clearpath Glaucoma Drainage Device.

Pre-market Notification Details

Device IDK182518
510k NumberK182518
Device Name:AHMED ClearPath Glaucoma Drainage Device
ClassificationImplant, Eye Valve
Applicant New World Medical, Inc. 10763 Edison Ct Rancho Cucamonga,  CA  91730
ContactMukesh Sabarad
CorrespondentMukesh Sabarad
New World Medical, Inc. 10763 Edison Ct Rancho Cucamonga,  CA  91730
Product CodeKYF  
CFR Regulation Number886.3920 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-09-13
Decision Date2019-01-18
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.