Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102)— 510(k) K233515

Name: FDA 510(k) clearance K233515
Creator: U.S. Food and Drug Administration
Published: 2023-12-26

Substantially Equivalent

Nuwellis, Inc.

FDA 510(k) clearance K233515 for Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Extended Length Catheter (dELC), 6F, 16 cm (320102), Substantially Equivalent on 2023-12-26. Applicant: Nuwellis, Inc.. Device class: 2.

Clearance details

Applicant: Nuwellis, Inc.
Product code: Code NQJ
Device class: Class 2
Regulation: 21 CFR 876.5540
Advisory panel: Gastroenterology, Urology
Date received: 2023-11-01
Decision date: 2023-12-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NQJ

view all

K252226 — Dual Lumen Extended Length Catheter (dELC), 6F, 12cm (320101) +1 more2025-08-13
K041791 — 5.2F DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)2004-09-10
K031689 — DUAL LUMEN EXTENDED LENGTH CATHETER (DELC)2003-12-23

Data sourced from openFDA. This site is unofficial and independent of the FDA.