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510(k) K233515

Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (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
December 26, 2023
Date Received
November 1, 2023
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 Nuwellis, Inc.

  • K252226 — Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extend (August 13, 2025)

Other clearances for product code NQJ

  • K252226 — Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extend (August 13, 2025)
  • K041791 — 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (September 10, 2004)
  • K031689 — DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (December 23, 2003)