Cleared Traditional

Aspira Pleural Drainage System

K212696 · Merit Medical Systems, Inc. · Anesthesiology
Mar 2023
Decision
555d
Days
Class 2
Risk

About This 510(k) Submission

K212696 is an FDA 510(k) clearance for the Aspira Pleural Drainage System, a Apparatus, Suction, Patient Care (Class II — Special Controls, product code DWM), submitted by Merit Medical Systems, Inc. (South Jordan, US). The FDA issued a Cleared decision on March 3, 2023, 555 days after receiving the submission on August 25, 2021. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 870.5050.

Submission Details

510(k) Number K212696 FDA.gov
FDA Decision Cleared SESE
Date Received August 25, 2021
Decision Date March 03, 2023
Days to Decision 555 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Summary PDF

Device Classification

Product Code DWM — Apparatus, Suction, Patient Care
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.5050

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