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
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.

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
Combination Product No
PCCP Authorized No
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 397
Devices cleared under the same product code (DWF) and FDA review panel - the closest regulatory comparables to K042984.
REMOTE ACCESS PERFUSION (RAP) FEMORAL VENOUS CANNULA
K052081 · Estech, Inc. · Dec 2005
BIO-MEDICUS MULTI-STAGE VENOUS FEMORAL PERCUTANEOUS KIT
K052524 · Medtronic Perfusion Systems · Nov 2005
MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C
K052372 · Medtronic Perfusion Systems · Sep 2005
SELECT 3D ARTERIAL CANNULA
K043179 · Medtronic Perfusion Systems · Feb 2005
CARDEON COBRA CATHETER
K042156 · Cardeon Corp. · Oct 2004
MICRO PRIME
K041650 · Innovx Medical, Inc. · Aug 2004
K042984 · INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C
Download PDF Intervascular