Cleared Traditional

K991674 - CORDIS PALMAZ CORINTHIAN TRANSHEPATIC B...

K991674 is an FDA 510(k) clearance for CORDIS PALMAZ CORINTHIAN TRANSHEPATIC B..., manufactured by Cordis Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K991674 · Cordis Corp. · Gastroenterology & Urology device
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Optimized for regulatory review, auditing and printing
Aug 1999
Decision
87d
Days
Class 2
Risk

K991674 is an FDA 510(k) clearance for the CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODE.... Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Cordis Corp. (Warren, US). The FDA issued a Cleared decision on August 12, 1999 after a review of 87 days - a notably fast clearance cycle.

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: 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 Cordis Corp. devices

FDA 510(k) Submission Details - K991674

510(k) Number K991674 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 17, 1999
Decision Date August 12, 1999
Days to Decision 87 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
43d faster than avg
Panel avg: 130d · This submission: 87d
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 317
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K991674.
PALMAZ XL TANSHEPATIC BILIARY STENTS
K993091 · Cordis Corp. · Oct 1999
RX MEGALINK SDS BILIARY STENT SYSTEM, OTW MEGALINK SDS BILIARY STENT SYSTEM
K992319 · Guidant Corp. · Oct 1999
RX HERCULINK 14 BILIARY STENT SYSTEM, MODEL 1005126-18,1005128-18,1005130-18,1005132-18,1005134-18,1005136-18,1005138-18
K990867 · Advanced Cardiovascular Systems, Inc. · Sep 1999
CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND ACCESSORIES
K991028 · Cordis Corp. · Aug 1999
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
K991793 · AngioDynamics, Inc. · Jun 1999
CYSTIC DUCT BALLOON DILATING CATHETER
K983154 · Applied Medical Resources · May 1999