Cleared Traditional

K052964 - EXXCEL AND EXXCEL SOFT EPTFE VASCULAR G...

K052964 is the FDA 510(k) clearance for EXXCEL AND EXXCEL SOFT EPTFE VASCULAR G... by Boston Scientific Corp. It is a Class 2 Cardiovascular device (product code DSY) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K052964 · Boston Scientific Corp · Cardiovascular device
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Jan 2006
Decision
77d
Days
Class 2
Risk

K052964 is an FDA 510(k) clearance for the EXXCEL AND EXXCEL SOFT EPTFE VASCULAR GRAFTS, MICROVEL DOUBLE VELOUR KNITTED .... Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on January 6, 2006 after a review of 77 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Boston Scientific Corp devices

Submission Details

510(k) Number K052964 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2005
Decision Date January 06, 2006
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 92
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K052964.
PTFE FLIXENE GRADUATED WALL GRAFT
K071923 · Atrium Medical Corp. · Aug 2007
GORE PROPATEN VASCULAR GRAFT
K062161 · W.L. Gore & Associates, Inc. · Nov 2006
ATRIUM FLIXENE GRAFT
K060124 · Atrium Medical Corp. · Mar 2006
ADVANTA T-GRAFT
K051332 · Atrium Medical Corp. · Sep 2005
LIFESPAN REINFORCED EPTFE STRAIGHT VASCULAR GRAFTS, EXTERNALLY SUPPORTED VASCULAR GRAFTS, STEPPED VASCULAR GRAFTS
K032900 · Edwards Lifesciences, LLC · Dec 2003
ADVANTA SST BIFURCATED GRAFT
K020767 · Atrium Medical Corp. · Apr 2002