Cleared Traditional

K953288 - DIASTAT VASCULAR ACCESS GRAFT

K953288 is an FDA 510(k) clearance for DIASTAT VASCULAR ACCESS GRAFT, manufactured by W.L. Gore & Associates, Inc.. The device is a Class 2 Cardiovascular device with product code DSY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K953288 · W.L. Gore & Associates, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1995
Decision
84d
Days
Class 2
Risk

K953288 is an FDA 510(k) clearance for the DIASTAT VASCULAR ACCESS GRAFT. Classified as Prosthesis, Vascular Graft, Of 6mm And Greater Diameter (product code DSY), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on October 6, 1995 after a review of 84 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 W.L. Gore & Associates, Inc. devices

FDA 510(k) Submission Details - K953288

510(k) Number K953288 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received July 14, 1995
Decision Date October 06, 1995
Days to Decision 84 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 125d · This submission: 84d
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 155
Devices cleared under the same product code (DSY) and FDA review panel - the closest regulatory comparables to K953288.
VASCUTEK GELSOFT PLUS VASCULAR GRAFT
K955230 · Vascutek, Ltd. · Feb 1996
VASCUTEK GELWEAVE VASCULAR GRAFT
K952293 · Vascutek, Ltd. · Dec 1995
BARD EXPANDED PTFE VASCULAR GRAFT(MODIFICATION)
K954582 · C.R. Bard, Inc. · Dec 1995
AXILLOBIFEMORAL GORE-TEX CASCULAR GRAFT,BIFURCATED
K941981 · W.L. Gore & Associates, Inc. · Jul 1994
BARD(R) EXPANDED PTFE VASCULAR GRAFT
K940816 · C.R. Bard, Inc. · Jun 1994
AOR-TEX VASCULAR GRAFT
K933987 · W.L. Gore & Associates, Inc. · May 1994