Cleared Special

ADVANTA GRAFT (K992441) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K992441 · Atrium Medical Corp. · Cardiovascular device
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Aug 1999
Decision
29d
Days
Class 2
Risk

K992441 is an FDA 510(k) clearance for the ADVANTA GRAFT. Classified as Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (product code DYF), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on August 20, 1999 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3450 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Atrium Medical Corp. devices

Submission Details

510(k) Number K992441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1999
Decision Date August 20, 1999
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code DYF Prosthesis, Vascular Graft, Of Less Then 6mm 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 - DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

All 9
Devices cleared under the same product code (DYF) and FDA review panel - the closest regulatory comparables to K992441.
PTFE RINGED GORE-TEX VASCULAR GRAFT
K991683 · W.L. Gore & Associates, Inc. · Sep 1999
DIASTAT VASCULAR ACCESS GRAFT
K955533 · W.L. Gore & Associates, Inc. · May 1996
DIASTAT VASCULAR ACCESS GRAFT
K953287 · W.L. Gore & Associates, Inc. · Oct 1995
BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT
K944844 · Baxter Healthcare Corp · Mar 1995
DIASTAT(TM) VASCULAR ACCESS GRAFT/CLASS III
K940824 · W.L. Gore & Associates, Inc. · May 1994
FEP RINGED GORE-TEX VASCULAR GRAFT
K934726 · W.L. Gore & Associates, Inc. · Dec 1993