Cleared Traditional

PATHWAY ACCESS SHEATH CATHETER (K030734) - FDA 510(k) Clearance

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

K030734 · Vertelink Corporation · Cardiovascular device
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Sep 2003
Decision
184d
Days
Class 2
Risk

K030734 is an FDA 510(k) clearance for the PATHWAY ACCESS SHEATH CATHETER. Classified as Introducer, Catheter (product code DYB), Class II - Special Controls.

Submitted by Vertelink Corporation (Mission Viejo, US). The FDA issued a Cleared decision on September 10, 2003 after a review of 184 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1340 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Vertelink Corporation devices

Submission Details

510(k) Number K030734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 10, 2003
Decision Date September 10, 2003
Days to Decision 184 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 125d · This submission: 184d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYB Introducer, Catheter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1340
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - DYB Introducer, Catheter

All 259
Devices cleared under the same product code (DYB) and FDA review panel - the closest regulatory comparables to K030734.
INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER
K033527 · B.Braun Medical, Inc. · Feb 2004
MODIFICATION TO CONVOY ADVANCED DELIVERY SHEATH
K034061 · Boston Scientific Corp · Jan 2004
CAPTIVA BLOOD CONTAINMENT DEVICE CN100, CAN19T71W
K031922 · Merit Medical Systems, Inc. · Oct 2003
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE
K032073 · W.L. Gore & Associates, Inc. · Aug 2003
SAFETY INTRODUCER NEEDLE
K030135 · B.Braun Medical, Inc. · Jul 2003
INTROCAN SAFETY IV CATHETER
K021094 · B.Braun Medical, Inc. · Jul 2002