Cleared Traditional

K113101 - EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL

K113101 is an FDA 510(k) clearance for EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDA..., manufactured by Boston Scientific Corporation. 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.

K113101 · Boston Scientific Corporation · Cardiovascular device
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Jan 2012
Decision
90d
Days
Class 2
Risk

K113101 is an FDA 510(k) clearance for the EXXCEL SOFT EPTEE VASCULAR GRAFT-STANDARD WALL,THIN WALL. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Boston Scientific Corporation (Wayne, US). The FDA issued a Cleared decision on January 17, 2012 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 Boston Scientific Corporation devices

FDA 510(k) Submission Details - K113101

510(k) Number K113101 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 2011
Decision Date January 17, 2012
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 153
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K113101.
ATRIUM FLIXENE IFG VASCULAR GRAFT
K122138 · Atrium Medical Corp. · Aug 2012
HERO GRAFT
K121532 · Hemosphere, Inc. · Jun 2012
HERO GRAFT
K120006 · Hemosphere, Inc. · Feb 2012
CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES
K103347 · Intervascular Sas · Feb 2011
ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT
K102596 · Atrium Medical Corp. · Oct 2010
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS
K093817 · Vascutek, Ltd. · Jan 2010