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

Apparatus, Autotransfusion

Atrium Medical Corporation

The following data is part of a premarket notification filed by Atrium Medical Corporation with the FDA for Auto Transfusion (ats) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain.

Pre-market Notification Details

Device IDK201305
510k NumberK201305
Device Name:Auto Transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain
ClassificationApparatus, Autotransfusion
Applicant Atrium Medical Corporation 40 Continental Blvd. Merrimack,  NH  03054
ContactRobin Mulvey
CorrespondentRobin Mulvey
Atrium Medical Corporation 40 Continental Blvd. Merrimack,  NH  03054
Product CodeCAC  
CFR Regulation Number868.5830 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-05-15
Decision Date2021-09-03

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