Home / 510(k) Clearances / K902759

510(k) K902759

COBE CLOSED WOUND DRAINAGE KIT by Cobe Laboratories, Inc. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 18, 1990
Date Received
June 25, 1990
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 Cobe Laboratories, Inc.

  • K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR (May 11, 1993)
  • K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC (March 22, 1991)
  • K905793 — COBE CENTRY 2 BICART OPTION KIT (February 12, 1991)
  • K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT (February 11, 1991)
  • K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR (December 27, 1990)
  • K902437 — COBE CARDIOTOMY RESERVOIR WITH OR WITHOUT FILTER (December 17, 1990)
  • K902631 — COBE ICU CONVERSION KIT (December 17, 1990)
  • K904566 — NEW COBE CENTRYSYSTEM(TM) 100 HG DIALYZER (December 12, 1990)
  • K902758 — COBE SATURATION/HEMATOCRIT MONITOR W/ FIBER OPTIC (August 23, 1990)
  • K902671 — COBE AUTOLOGOUS BLOOD SALVAGE RESERV W/W/O FILTER (July 17, 1990)

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)