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FDA 510(k)

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

K-Number: K201305 · 2021-09-03

ApplicantAtrium Medical Corporation
Decision Date2021-09-03
Product CodeCAC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain is a medical device manufactured by Atrium Medical Corporation. It received FDA 510(k) clearance on 2021-09-03 under approval number K201305. The device is classified under product code CAC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain is a medical device that received FDA 510(k) clearance on 2021-09-03. It is manufactured by Atrium Medical Corporation. The 510(k) number is K201305.

When was Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain approved by the FDA?

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain received FDA 510(k) clearance on 2021-09-03, under approval number K201305.

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

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain is manufactured by Atrium Medical Corporation.

What is the FDA product code for Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain?

The FDA product code for Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain is CAC.

Related Clinical Trials

NCT07387380 KIRA Uterine Drain Device Evaluation- First-In- Human Study COMPLETED NCT06938607 Post-operative Outcomes of Anterior Cervical Discectomy and Fusion Surgery With and Without Drain Placement NOT_YET_RECRUITING NCT06958848 16F vs 24F Chest Drain After Minimally Invasive Lobectomy and/or Segmentectomy RECRUITING NCT06219538 DAISY Uterine Drain Device Evaluation COMPLETED NCT07527702 Low (-4) vs Physiologic (-8) Pressure Digital Continuous Suction After Lung Resection RECRUITING NCT05975359 Assessment of the Interi Manifold in Implant-Based Breast Reconstruction RECRUITING

Other Devices by Atrium Medical Corporation

K231972Advanta VXT Vascular Graft, Flixene Vascular Graft

Related Devices (Code: CAC)

K160735CATSmartFresenius Kabi AG K160197Haemonetics Cell Saver Elite Autotransfusion SystemHaemonetics Corporation K162423Haemonetics Cell Saver Elite/Elite+ Autotransfusion SystemHaemonetics Corporation K180831CATSmartFresenius Kabi AG K181954autoLog IQ Autotransfusion SystemMedtronic Perfusion Systems K192368CATSmartFresenius Kabi AG

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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