Cleared Traditional

DUAL LUMEN EXTENDED LENGTH CATHETER (DELC) (K031689) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K031689 · Chf Solutions, Inc. · Gastroenterology & Urology device
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Dec 2003
Decision
204d
Days
Class 2
Risk

K031689 is an FDA 510(k) clearance for the DUAL LUMEN EXTENDED LENGTH CATHETER (DELC). Classified as Catheter, Hemodialysis, Non-implanted, Ultrafiltration, For Peripheral Use (product code NQJ), Class II - Special Controls.

Submitted by Chf Solutions, Inc. (Brooklyn Park, US). The FDA issued a Cleared decision on December 23, 2003 after a review of 204 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Gastroenterology & Urology review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K031689 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2003
Decision Date December 23, 2003
Days to Decision 204 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 130d · This submission: 204d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.