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510(k) K201305

Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suction Water Seal Chest Drain, Express Dry Seal Chest Drain by Atrium Medical Corporation — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 2021
Date Received
May 15, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Autotransfusion
Device Class
Class II
Regulation Number
868.5830
Review Panel
CV
Submission Type

Other clearances by Atrium Medical Corporation

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  • K151386 — C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic (October 22, 2015)
  • K151437 — ProLite Mesh, ProLite Ultra Mesh, ProLoop Mesh Plug (August 27, 2015)
  • K130142 — FLIXENE IFG VASCULAR GRAFT (March 15, 2013)
  • K110110 — ATRIUM CENTRILFX MESH (February 15, 2011)

Other clearances for product code CAC

  • K241236 — XTRA Collection sets; XTRA Sequestration set X (August 16, 2024)
  • K240426 — Aventus Clot Management System (May 14, 2024)
  • K240584 — XTRA Autotransfusion System (with XTRA Bowl sets) (April 29, 2024)
  • K231782 — FlowSaver Blood Return System (80-101) (July 14, 2023)
  • K221483 — FlowSaver Blood Return System (February 17, 2023)
  • K221722 — Haemonetics Cell Saver Elite/Elite+ Autotransfusion System (CSE-E-US/CSE-EW-US) (November 15, 2022)
  • K210862 — Hemafuse System (July 29, 2021)
  • K210176 — FlowSaver Blood Filter (July 22, 2021)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)
  • K193361 — ProCell Surgical Sponge-Blood Recovery Unit (June 1, 2020)