Cleared Traditional

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

K233515 is an FDA 510(k) clearance for Dual Lumen Extended Length Catheter (dELC), manufactured by Nuwellis, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code NQJ cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K233515 · Nuwellis, Inc. · Gastroenterology & Urology device
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Dec 2023
Decision
55d
Days
Class 2
Risk

K233515 is an FDA 510(k) clearance for the Dual Lumen Extended Length Catheter (dELC), 6F, 12 cm (320101), Dual Lumen Ex.... Classified as Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use (product code NQJ), Class II - Special Controls.

Submitted by Nuwellis, Inc. (Eden Prairie, US). The FDA issued a Cleared decision on December 26, 2023 after a review of 55 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5540 - the FDA gastroenterology and urology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nuwellis, Inc. devices

FDA 510(k) Submission Details - K233515

510(k) Number K233515 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2023
Decision Date December 26, 2023
Days to Decision 55 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
76d faster than avg
Panel avg: 131d · This submission: 55d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQJ Device Classification - Class 2, Special Controls

Product Code NQJ Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5540
Definition 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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Gastroenterology & Urology devices follow this clearance model.