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510(k) K060008

AQUADEX FLEXFLOW SYSTEM by Chf Solutions, Inc. — Product Code KDI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 2, 2006
Date Received
January 3, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dialyzer, High Permeability With Or Without Sealed Dialysate System
Device Class
Class II
Regulation Number
876.5860
Review Panel
GU
Submission Type

Other clearances by Chf Solutions, Inc.

  • K192756 — Aquadex FlexFlow System 2.0 (February 24, 2020)
  • K071854 — AQUADEX FLEXFLOW SYSTEM (September 7, 2007)
  • K070512 — MODIFICATION TO AQUADEX FLEXFLOW SYSTEM (April 27, 2007)
  • K062922 — MODIFICATION TO AQUADEX FLEXFLOW SYSTEM (December 13, 2006)
  • K050609 — AQUADEX SYSTEM (November 9, 2005)
  • K041791 — 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (September 10, 2004)
  • K040489 — AQUADEX SYSTEM 100, MODEL A1100 (April 27, 2004)
  • K031689 — DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (December 23, 2003)
  • K023874 — SYSTEM 100 ULTRAFILTRATION CATHETER (November 20, 2003)
  • K024124 — SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT (March 14, 2003)

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  • K243505 — 5008X Hemodialysis System (May 30, 2025)
  • K242155 — DBB-06 PRO Hemodialysis Delivery System (DBB-06 PRO) (May 15, 2025)
  • K243264 — DHF 0.2 Hemoconcentrator (DHF 02); DHF 0.6 Hemoconcentrator (DHF 06); SH 14 Hemo (April 25, 2025)