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510(k) K252226

Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102) by Nuwellis, Inc. — Product Code NQJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2025
Date Received
July 16, 2025
Clearance Type
Special
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 Nuwellis, Inc.

  • K233515 — Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Exten (December 26, 2023)

Other clearances for product code NQJ

  • 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)
  • K031689 — DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (December 23, 2003)