Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101) +1 more— 510(k) K252226

Name: FDA 510(k) clearance K252226
Creator: U.S. Food and Drug Administration
Published: 2025-08-13

Substantially Equivalent

Nuwellis, Inc.

FDA 510(k) clearance K252226 for Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101) +1 more, Substantially Equivalent on 2025-08-13. Applicant: Nuwellis, Inc.. Device class: 2.

Clearance details

Device name as filed: Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101); Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)
Applicant: Nuwellis, Inc.
Product code: Code NQJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2025-07-16
Decision date: 2025-08-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQJ

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K233515 — Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)2023-12-26
K041791 — 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)2004-09-10
K031689 — DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)2003-12-23

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