Cleared Special

K000793 - 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER

K000793 is an FDA 510(k) clearance for 1 OTW VIATRAC 18 PERIPHERAL DILATATION ..., manufactured by Guidant Corp.. The device is a Class 2 Gastroenterology & Urology device with product code FGE cleared through the Special 510(k) pathway after a 30-day FDA review.

K000793 · Guidant Corp. · Gastroenterology & Urology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2000
Decision
30d
Days
Class 2
Risk

K000793 is an FDA 510(k) clearance for the 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER. Classified as Stents, Drains And Dilators For The Biliary Ducts (product code FGE), Class II - Special Controls.

Submitted by Guidant Corp. (Temecula, US). The FDA issued a Cleared decision on April 12, 2000 after a review of 30 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K000793

510(k) Number K000793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 2000
Decision Date April 12, 2000
Days to Decision 30 days
Submission Type Special
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
101d faster than avg
Panel avg: 131d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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 477
Devices cleared under the same product code (FGE) and FDA review panel - the closest regulatory comparables to K000793.
OTW MEGALINK SDS BILLIARY STENT SYSTEM, MODELS 1005509-18, 1005510-18, 1005511-18, 1005512-18, 1005509-28, 1005510-28, 1
K001222 · Guidant Corp. · May 2000
RX HERCULINK 14 BILIARY STENT SYSTEM, MODELS 1005127-13, 1005129-13, 1005131-13, 1005133-13, 1005135-13, 1005137-13, 100
K001224 · Guidant Corp. · May 2000
INTRASTENT DOUBLESTRUT XS STENT
K000864 · Intratherapeutics, Inc. · Apr 2000
CORDIS MEDIUM PALMAZ TRANSHEPATIC BILIARY STENT & DELIVERY
K000564 · Cordis Corp. · Mar 2000
SEMI COMPLIANT (SC) 35 BALLOON DILATATION CATHETER
K993303 · Boston Scientific Corp · Mar 2000
OTW MEGALINK SDS BILIARY STENT SYSTEM
K000550 · Advanced Cardiovascular Systems, Inc. · Mar 2000
K000793 · 1 OTW VIATRAC 18 PERIPHERAL DILATATION CATHETER
Download PDF FDA Summary Guidant Corp.