Cleared Traditional

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain

K201305 · Atrium Medical Corporation · Cardiovascular

Sep 2021

Decision

476d

Days

Class 2

Risk

About This 510(k) Submission

K201305 is an FDA 510(k) clearance for the Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain, a Apparatus, Autotransfusion (Class II — Special Controls, product code CAC), submitted by Atrium Medical Corporation (Hudson, US). The FDA issued a Cleared decision on September 3, 2021, 476 days after receiving the submission on May 15, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 868.5830.

Submission Details

510(k) Number	K201305 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 15, 2020
Decision Date	September 03, 2021
Days to Decision	476 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF