Cleared Traditional

PATHWAY ACCESS SHEATH CATHETER (K030662) - FDA 510(k) Clearance

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

K030662 · Vertelink Corporation · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2003
Decision
184d
Days
Class 2
Risk

K030662 is an FDA 510(k) clearance for the PATHWAY ACCESS SHEATH CATHETER. Classified as Dilator, Catheter, Ureteral (product code EZN), Class II - Special Controls.

Submitted by Vertelink Corporation (Mission Viejo, US). The FDA issued a Cleared decision on September 3, 2003 after a review of 184 days - an extended review cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5470 - 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 Vertelink Corporation devices

Submission Details

510(k) Number K030662 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2003
Decision Date September 03, 2003
Days to Decision 184 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 130d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EZN Dilator, Catheter, Ureteral
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5470
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 - EZN Dilator, Catheter, Ureteral

All 21
Devices cleared under the same product code (EZN) and FDA review panel - the closest regulatory comparables to K030662.
Balloon Catheter and Balloon Ureteral Dilator Set
K172588 · Cook Incorporated · Apr 2018
UROMAX ULTRA BALLOON DILATATION CATHETER
K130804 · Boston Scientific Corporation · May 2013
U-BALLOON DILATION CATHETER
K050875 · C.R. Bard, Inc. · May 2005
BARD UROFORCE BALLOON DILATION CATHETER
K993840 · C.R. Bard, Inc. · Jan 2000
UROLOGICAL BALLOON DILATATION CATHETER
K980795 · Boston Scientific Corp · Apr 1998
BARD A-TRAC UROLOGICAL BALLOON DILATION CATHETER
K962921 · C.R. Bard, Inc. · Oct 1996