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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 K221779
Device Name ASEPT Peritoneal Drainage System
Applicant
Pfm Medical, Inc.
1916 Palomar Oaks Way Suite 150
Carlsbad,  CA  92008
Applicant Contact Jessica Jho
Correspondent
Pfm Medical, Inc.
1916 Palomar Oaks Way Suite 150
Carlsbad,  CA  92008
Correspondent Contact Jessica Jho
Regulation Number876.5630
Classification Product Code
PNG  
Date Received06/21/2022
Decision Date 05/02/2023
Decision Substantially Equivalent - Kit (SESK)
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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