Cleared Special

Aspira Peritoneal Drainage System

K212675 · Merit Medical Systems, Inc. · Gastroenterology & Urology
Dec 2021
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K212675 is an FDA 510(k) clearance for the Aspira Peritoneal Drainage System, a Peritoneal, Drainage Catheter For Refractory Ascites, Long-term Indwelling (Class II — Special Controls, product code PNG), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on December 14, 2021, 112 days after receiving the submission on August 24, 2021. This device falls under the Gastroenterology & Urology review panel. Regulated under 21 CFR 876.5630.

Submission Details

510(k) Number K212675 FDA.gov
FDA Decision Cleared SESK
Date Received August 24, 2021
Decision Date December 14, 2021
Days to Decision 112 days
Submission Type Special
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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