Cleared Traditional

K004011 - IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS

K004011 is an FDA 510(k) clearance for IMPRA CARBOFLO VASCULAR GRAFT, manufactured by Impra, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K004011 · Impra, Inc. · Cardiovascular device
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Mar 2001
Decision
90d
Days
Class 2
Risk

K004011 is an FDA 510(k) clearance for the IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Impra, Inc. (Tempe, US). The FDA issued a Cleared decision on March 27, 2001 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - 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 Impra, Inc. devices

FDA 510(k) Submission Details - K004011

510(k) Number K004011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 27, 2000
Decision Date March 27, 2001
Days to Decision 90 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 125d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSY Device Classification - Class 2, Special Controls

Product Code DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3450
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 - DSY Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

All 166
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K004011.
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
K012952 · Boston Scientific/Medi-Tech · Oct 2001
ADVANTA SST GRAFT (>_6MM)
K010516 · Atrium Medical Corp. · May 2001
ADVANTA SST GRAFT (<6MM)
K010517 · Atrium Medical Corp. · May 2001
SULZER VASCUTEK GELSOFT ERS VASCULAR PROSTHESIS
K002007 · Sulzer Carbomedics, Inc. · Jan 2001
INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS
K990800 · Intervascular, Inc. · Jan 2001
VECTRA (TM) VASCULAR ACCESS GRAFT-5MM DIAMETER,6MM DIAMETER AND VECTRA (TM) VASCULAR ACCESS GRAFT FOR REVISION-5MM DIAME
K001927 · Thoratec Laboratories Corp. · Dec 2000