Cleared Special

K992960 - ADVANTA GRAFT (>6MM)

K992960 is an FDA 510(k) clearance for ADVANTA GRAFT (>6MM), manufactured by Atrium Medical Corp.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Special 510(k) pathway after a 29-day FDA review.

K992960 · Atrium Medical Corp. · Cardiovascular device
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Oct 1999
Decision
29d
Days
Class 2
Risk

K992960 is an FDA 510(k) clearance for the ADVANTA GRAFT (>6MM). Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Atrium Medical Corp. (Hudson, US). The FDA issued a Cleared decision on October 1, 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

FDA 510(k) Submission Details - K992960

510(k) Number K992960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 02, 1999
Decision Date October 01, 1999
Days to Decision 29 days
Submission Type Special
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
96d faster than avg
Panel avg: 125d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 125
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K992960.
ADVANTA SST GRAFT (<6MM)
K010517 · Atrium Medical Corp. · May 2001
IMPRA CARBOFLO VASCULAR GRAFT, IMPRA CARBOFLO VASCULAR GRAFTS FOR A-V ACCESS
K004011 · Impra, Inc. · Mar 2001
ADVANTA SUPER SOFT GRAFT
K000499 · Atrium Medical Corp. · Mar 2000
ADVANTA GRAFT
K992443 · Atrium Medical Corp. · Aug 1999
EPTFE RINGED GORE-TEX VASCULAR GRAFT
K991602 · W.L. Gore & Associates, Inc. · Jul 1999
UNI-GRAFT K DV VASCULAR GRAFT
K991813 · Atrium Medical Corp. · Jun 1999