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510(k) K022348

ACCESS CONCENTRATION SYSTEM, MODEL ACC-100, ACCESS DISPOSABLE SET, MODEL ADS-2000 by Interpore Cross Intl. — Product Code CAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2002
Date Received
July 19, 2002
Clearance Type
Special
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 Interpore Cross Intl.

  • K050861 — PEEK CAS (May 27, 2005)
  • K031399 — INTERGRO DBM (February 18, 2005)
  • K041407 — TITANIUM MESH IMPLANT (December 29, 2004)
  • K043229 — MODIFICATION TO ALTIUS OCT SYSTEM (December 21, 2004)
  • K042798 — C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM (November 4, 2004)
  • K040928 — EXPANDABLE PEEK VBR IMPLANT (August 27, 2004)
  • K041794 — C-TEK C-THRU ANTERIOR CERVICAL PLATE SYSTEM (July 19, 2004)
  • K041449 — SYNERGY HELICAL FLANGE PLUG, HELICAL FLANGE SEAT AND HELICAL FLANGE REDUCTION SE (July 1, 2004)
  • K033961 — ALTIUS OCT SYSTEM (April 14, 2004)
  • K040168 — MODIFICATION TO GEO STRUCTURE (April 8, 2004)

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)