Cleared Traditional

K042984 - INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C

K042984 is an FDA 510(k) clearance for INTERGARD WOVEN CONNECTOR GRAFT, manufactured by Intervascular. The device is a Class 2 Cardiovascular device with product code DWF cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K042984 · Intervascular · Cardiovascular device
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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

FDA 510(k) Submission Details - K042984

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.

DWF Device Classification - Class 2, Special Controls

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 322
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