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510(k) K070512

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 2007
Date Received
February 22, 2007
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)
  • K062922 — MODIFICATION TO AQUADEX FLEXFLOW SYSTEM (December 13, 2006)
  • K060008 — AQUADEX FLEXFLOW SYSTEM (February 2, 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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  • K253518 — FX CorAL 40; FX CorAL 50 (December 18, 2025)
  • K243920 — Purema H Hemoconcentrator - Pediatric (September 19, 2025)
  • K250508 — AK 98 Dialysis Machine (955607) (August 1, 2025)
  • K243237 — 2008T HD SYS. CDX BLUESTAR (191124); 2008T HD SYS. CDX W/bibag BLUESTAR (191126) (June 13, 2025)
  • 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)