Cleared Traditional

DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML (K030638) - FDA 510(k) Clearance

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

K030638 · Avantec Vascular Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2003
Decision
131d
Days
Class 2
Risk

K030638 is an FDA 510(k) clearance for the DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Avantec Vascular Corp. (Sunnyvale, US). The FDA issued a Cleared decision on July 9, 2003 after a review of 131 days - within the typical 510(k) review window.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5010 - 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.

View all Avantec Vascular Corp. devices

Submission Details

510(k) Number K030638 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 28, 2003
Decision Date July 09, 2003
Days to Decision 131 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
1d slower than avg
Panel avg: 130d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FGE Stents, Drains And Dilators For The Biliary Ducts
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5010
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.

Regulatory Peers - FGE Stents, Drains And Dilators For The Biliary Ducts

All 473
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K030638.
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