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510(k) K014083

HAEMONETICS CELL SAVER 5 AUTOLOGOUS BLOOD RECOVERY SYSTEM by Haemonetics Corp. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 2002
Date Received
December 11, 2001
Clearance Type
Special
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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  • K062801 — SMARTSUCTION SOLO DEVICE (October 4, 2006)
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  • K052626 — SMARTSUCTION HARMONY DEVICE (October 5, 2005)
  • K043127 — HAEMONETICS CARDIOVASCULAR PERIOPERATIVE AUTOTRANSFUSION SYSTEM (January 4, 2005)
  • K993581 — HAEMONETICS LN 193 DISPOSABLE SET, FOR USE WITH THE HAEMONETICS CELLSEVER HAEMOL (November 18, 1999)

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  • K210862 — Hemafuse System (July 29, 2021)
  • K210176 — FlowSaver Blood Filter (July 22, 2021)
  • K210089 — CATSmart, Automated Blood Processing Autotransfusion System (February 11, 2021)