Home / 510(k) Clearances / K022489

510(k) K022489

SUMMIT MEDICAL LTD CELLTRANS POSTOPERATIVE AUTOTRANSFUSION SYSTEM, MODELS ABT4510, ABT4512 & ABT4514 by Summit Medical , Ltd. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 9, 2002
Date Received
July 29, 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 Summit Medical , Ltd.

  • K180528 — InstruSafe(R) Sterilization Container (November 16, 2018)
  • K173110 — GRAFTSITE (May 18, 2018)
  • K170388 — ANCHORMAN Tibial Ligament Fixation Device (July 25, 2017)
  • K162046 — MINNE TIES MMF Suture System (April 11, 2017)
  • K151166 — Instru-Safe Instrument Protection System (August 18, 2015)
  • K150540 — Instru-Safe Instrument Protection System (June 22, 2015)
  • K142768 — Instru-Safe Instrument Protection System (May 29, 2015)
  • K142630 — Instru-Safe Instrument Protection System (December 23, 2014)
  • K141513 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (December 15, 2014)
  • K140289 — INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM (June 27, 2014)

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)