Cleared Traditional

INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C (K042984) - FDA 510(k) Clearance

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

K042984 · Intervascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2005
Decision
112d
Days
Class 2
Risk

K042984 is an FDA 510(k) clearance for the INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C. Classified as Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (product code DWF), Class II - Special Controls.

Submitted by Intervascular (Canton, US). The FDA issued a Cleared decision on February 18, 2005 after a review of 112 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4210 - 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 Intervascular devices

Submission Details

510(k) Number K042984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 2004
Decision Date February 18, 2005
Days to Decision 112 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
13d faster than avg
Panel avg: 125d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4210
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 - DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

All 103
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K042984.
MEDTRONIC CLEAR INTRAVACULAR ARTERIOTOMY SHUNT
K120612 · Medtronic, Inc. · May 2012
MEDLINE VESSEL CANNULA
K111147 · Medline Industries, Inc. · Jul 2011
MIAR (MINIMALLY INVASIVE AORTIC ROOT) CANNULA WITH FLOW-GUARD, MODELS 11012L AND 11014L
K100274 · Medtronic, Inc. · May 2010
SPHERICAL TIP CORONARY OSTIAL CANNULA, MODEL 30011
K034058 · Medtronic Vascular · Jan 2004
EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX,
K031518 · Medtronic Vascular · May 2003
ONE PIECE PEDIATRIC ARTERIAL CANNULA, MODEL: 77006, 77106
K024069 · Medtronic Vascular · Jan 2003