The following data is part of a premarket notification filed by New World Medical, Inc. with the FDA for Ahmed Clearpath Glaucoma Drainage Device.
Device ID | K182518 |
510k Number | K182518 |
Device Name: | AHMED ClearPath Glaucoma Drainage Device |
Classification | Implant, Eye Valve |
Applicant | New World Medical, Inc. 10763 Edison Ct Rancho Cucamonga, CA 91730 |
Contact | Mukesh Sabarad |
Correspondent | Mukesh Sabarad New World Medical, Inc. 10763 Edison Ct Rancho Cucamonga, CA 91730 |
Product Code | KYF |
CFR Regulation Number | 886.3920 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2018-09-13 |
Decision Date | 2019-01-18 |
Summary: | summary |