Cleared Traditional

K910865 - TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS

K910865 is an FDA 510(k) clearance for TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS, manufactured by Vascutek, Ltd.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 31-day FDA review.

K910865 · Vascutek, Ltd. · Cardiovascular device
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Apr 1991
Decision
31d
Days
Class 2
Risk

K910865 is an FDA 510(k) clearance for the TRIAXIL (VP50K) KNITTED VASCULAR PROSTHESIS. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by Vascutek, Ltd. (Pa49rr Scotland, GB). The FDA issued a Cleared decision on April 1, 1991 after a review of 31 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 Vascutek, Ltd. devices

FDA 510(k) Submission Details - K910865

510(k) Number K910865 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 1991
Decision Date April 01, 1991
Days to Decision 31 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d faster than avg
Panel avg: 125d · This submission: 31d
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 125
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K910865.
GORE-TEX(R) VASCULAR GRAFTS, PROCESS CHANGE
K914447 · W.L. Gore & Associates, Inc. · Nov 1991
EXTRA SOFT/EXTRA LOW WOVEN VASCULAR PROTHESIS
K910863 · Vascutek, Ltd. · Apr 1991
EXTERNALLY REINFORCED TRIAXIAL PROSTHESIS
K910864 · Vascutek, Ltd. · Apr 1991
VASCUSOFT (VP1200K) KNITTED VASCULAR PROSTHESIS
K910866 · Vascutek, Ltd. · Apr 1991
BIFURCATED GORE TEX STRETCH VASCULAR GRAFT
K904282 · W.L. Gore & Associates, Inc. · Jan 1991
GORE-TEX(R) STRETCH VASCULAR GRAFT
K903931 · W.L. Gore & Associates, Inc. · Dec 1990