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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Eye Valve
510(k) Number K182518
Device Name AHMED ClearPath Glaucoma Drainage Device
Applicant
New World Medical, Inc.
10763 Edison Ct.
Rancho Cucamonga,  CA  91730
Applicant Contact Mukesh Sabarad
Correspondent
New World Medical, Inc.
10763 Edison Ct.
Rancho Cucamonga,  CA  91730
Correspondent Contact Mukesh Sabarad
Regulation Number886.3920
Classification Product Code
KYF  
Date Received09/13/2018
Decision Date 01/18/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ophthalmic
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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