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510(k) K791891

ACU-MED RED MISER HEMOTHORAX BLOOD COLL. by Acumed Instruments Corp. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1979
Date Received
September 25, 1979
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 Acumed Instruments Corp.

  • K863627 — MICRO SURGICAL DRILL SYSTEM (October 2, 1986)
  • K853658 — BURS FOR MICRO SURGICAL DRILL SYSTEM (September 24, 1985)
  • K853660 — MICRO SURGICAL DRILL SYSTEM (September 24, 1985)
  • K853659 — POWERED IRRIGATION FOR MICRO SURGICAL DRILL (September 24, 1985)
  • K791399 — ACU-ALERT (October 11, 1979)
  • K791400 — GASTRIC LAVAGE KIT-DISPOSABLE (August 16, 1979)
  • K790901 — I.V. TUBING ORGANIZER (June 27, 1979)

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)