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510(k) K031689

DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) by Chf Solutions, Inc. — Product Code NQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 23, 2003
Date Received
June 2, 2003
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Hemodialysis, Non-Implanted, Ultrafiltration, For Peripheral Use
Device Class
Class II
Regulation Number
876.5540
Review Panel
GU
Submission Type

Dual lumen, non-implanted, peripheral access catheters are inserted in the peripheral arm vein and are indicated for temporary (up to 8 hours) ultrafiltration treatment of patients with fluid overload.

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)
  • 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)
  • K023874 — SYSTEM 100 ULTRAFILTRATION CATHETER (November 20, 2003)
  • K024124 — SYSTEM 100-UF 500 CIRCUIT WITH IN-LINE NEEDLELESS ACCESS PORT (March 14, 2003)

Other clearances for product code NQJ

  • K252226 — Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extend (August 13, 2025)
  • K233515 — Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Exten (December 26, 2023)
  • K041791 — 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (September 10, 2004)