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510(k) K120586

CELL SAVER ELITE by Haemonetics Corp. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 22, 2012
Date Received
February 27, 2012
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

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  • K101907 — HAEMONETICS CELL SAVER ELITE AUTOTRANSFUSION SYSTEM (December 3, 2010)
  • K062801 — SMARTSUCTION SOLO DEVICE (October 4, 2006)
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  • K053000 — HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (CARDIOPAT) (November 21, 2005)
  • K052626 — SMARTSUCTION HARMONY DEVICE (October 5, 2005)
  • K043127 — HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (January 4, 2005)
  • K014083 — HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM (January 8, 2002)
  • K993581 — HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOL (November 18, 1999)

Other clearances for product code CAC

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  • 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)
  • K201305 — Auto transfusion (ATS) Chest Drains: Ocean Water Seal Chest Drain, Oasis Dry Suc (September 3, 2021)
  • K210862 — Hemafuse System (July 29, 2021)
  • K210176 — FlowSaver Blood Filter (July 22, 2021)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)