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510(k) K022167

PALL DONER PRE-EVACUATED POST-OPERATIVE AUTOLOGOUS BLOOD REINFUSION SYSTEM by Pall Corp. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 2003
Date Received
July 3, 2002
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 Pall Corp.

  • K993379 — PALL SUPOR AEF FILTER (December 16, 1999)
  • K980762 — PALL STAT-PRIME D BLOOD FILTER FOR EXTRACORPOREAL SERVICE (September 1, 1998)

Other clearances for product code CAC

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  • 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)
  • 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)