Cleared Traditional

K040413 - CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY...

K040413 is an FDA 510(k) clearance for CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY..., manufactured by Cordis Europa, N.V.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 124-day FDA review.

K040413 · Cordis Europa, N.V. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Jun 2004
Decision
124d
Days
Class 2
Risk

K040413 is an FDA 510(k) clearance for the CORDIS PALMAZ BLUE TRANSHEPATIC BILIARY STENT ON SLALOM .018 DELIVERY SYSTEM. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cordis Europa, N.V. (Warren, US). The FDA issued a Cleared decision on June 21, 2004 after a review of 124 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 Cordis Europa, N.V. devices

FDA 510(k) Submission Details - K040413

510(k) Number K040413 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received February 18, 2004
Decision Date June 21, 2004
Days to Decision 124 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
6d faster than avg
Panel avg: 130d · This submission: 124d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FGE Device Classification - Class 2, Special Controls

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 314
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K040413.
EXTRACTOR RX RETRIEVAL BALLOON
K041606 · Boston Scientific Corp · Jul 2004
ZILVER BILIARY STENT SYSTEM USW
K040930 · Wilson-Cook Medical, Inc. · Jul 2004
WILOSN-COOK BILIARY DILATION BALLOON
K040800 · Wilson-Cook Medical, Inc. · Jun 2004
PARAMOUNT MINI GPS BILIARY STENT SYSTEM
K040653 · Ev3, Inc. · Apr 2004
XPERT BILIARY STENT, MODELS EX8L6006, EX8L3008, EX8L4008, EX8L6008, EX8S6006, EX8S3008, EX8S4008, EX8S6008
K040667 · Abbott Laboratories · Apr 2004
BOSTON SCIENTIFIC EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM
K040027 · Boston Scientific · Mar 2004