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510(k) K812355

IBM 2991 BLOOD CELL PROCESSOR MOD. 1 & 2 by Intl. Business Machines — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 9, 1981
Date Received
August 19, 1981
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 Intl. Business Machines

  • K831004 — AUTOMATED 8400 BLOOD CELL SEPARATOR (September 12, 1983)
  • K830163 — IBM 588 DIGITAL ECG ACQUISITION/ANALYSIS (February 18, 1983)
  • K810988 — IBM 5885 DIGITAL ECG ACQUISITION CART (May 1, 1981)
  • K810989 — IBM 5880 ACQUISITION & ANALYSIS CART TEL (May 1, 1981)
  • K772353 — EKG ACQUISITION & ANALYSIS CART (January 6, 1978)
  • K771258 — BLOOD CELL SEPARATOR 2997 (September 6, 1977)
  • K760856 — BLOOD CELL PROCESSOR MODEL 2 IBM 2991 (January 10, 1977)

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)
  • 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)