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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Peritoneal, Drainage Catheter For Refractory Ascites, Long-Term Indwelling
510(k) Number K241278
Device Name ASEPT® Glide Peritoneal Drainage System
Applicant
Pfm Medical, Inc.
1916 Palomar Oaks Way Suite 150
Carlsbad,  CA  92008
Applicant Contact Madison Reid
Correspondent
Pfm Medical, Inc.
1916 Palomar Oaks Way Suite 150
Carlsbad,  CA  92008
Correspondent Contact Madison Reid
Regulation Number876.5630
Classification Product Code
PNG  
Subsequent Product Code
EZL  
Date Received05/06/2024
Decision Date 01/14/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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