Cleared Traditional

K991533 - MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION

K991533 is an FDA 510(k) clearance for MEDTRONIC AVE STENT DELIVERY SYSTEM - F..., manufactured by Peripheral Ave. 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.

K991533 · Peripheral Ave · Gastroenterology & Urology device
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Jul 1999
Decision
87d
Days
Class 2
Risk

K991533 is an FDA 510(k) clearance for the MEDTRONIC AVE STENT DELIVERY SYSTEM - FOR USE IN BILIARY INDICATION. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Peripheral Ave (Santa Rosa, US). The FDA issued a Cleared decision on July 29, 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 Peripheral Ave devices

FDA 510(k) Submission Details - K991533

510(k) Number K991533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received May 03, 1999
Decision Date July 29, 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
44d faster than avg
Panel avg: 131d · 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 412
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K991533.
INTRASTENT
K991929 · Intratherapeutics, Inc. · Aug 1999
INNERDYNE RADIALLY EXPANDING DILATION, RED DEVICE
K990854 · Innerdyne, Inc. · Aug 1999
MEDTRONIC AVE BRIDGE STENT
K992318 · Medtronic Ave, Inc. · Aug 1999
ANGIODYNAMICS BALLOON EXPANDABLE BILIARY STENT SYSTEM
K991793 · AngioDynamics, Inc. · Jun 1999
CYSTIC DUCT BALLOON DILATING CATHETER
K983154 · Applied Medical Resources · May 1999
CORDIA PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELIVERY SYSTEM, MODEL PC125BPS, PC126BPS, PC127BPS,PC128BPS, PC
K990631 · Cordis Corp. · Apr 1999