Cleared Traditional

ASEPT Peritoneal Drainage System

K221779 · Pfm Medical, Inc. · Gastroenterology & Urology
May 2023
Decision
315d
Days
Class 2
Risk

About This 510(k) Submission

K221779 is an FDA 510(k) clearance for the ASEPT Peritoneal Drainage System, a Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (Class II — Special Controls, product code PNG), submitted by Pfm Medical, Inc. (Carlsbad, US). The FDA issued a Cleared decision on May 2, 2023, 315 days after receiving the submission on June 21, 2022. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K221779 FDA.gov
FDA Decision Cleared SESK
Date Received June 21, 2022
Decision Date May 02, 2023
Days to Decision 315 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF

Device Classification

Product Code PNG — Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling
Device Class Class II — Special Controls
CFR Regulation 21 CFR 876.5630
Definition For Drainage Of Refractory Ascites With Long-term Occurrence From The Peritoneal Cavity.

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