Cleared Traditional

K955533 - DIASTAT VASCULAR ACCESS GRAFT

K955533 is the FDA 510(k) clearance for DIASTAT VASCULAR ACCESS GRAFT by W.L. Gore & Associates, Inc.. It is a Class 2 Cardiovascular device (product code DYF) cleared through the Traditional 510(k) pathway after a 162-day FDA review.

K955533 · W.L. Gore & Associates, Inc. · Cardiovascular device
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May 1996
Decision
162d
Days
Class 2
Risk

K955533 is an FDA 510(k) clearance for the DIASTAT VASCULAR ACCESS GRAFT. Classified as Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (product code DYF), Class II - Special Controls.

Submitted by W.L. Gore & Associates, Inc. (Flagstaff, US). The FDA issued a Cleared decision on May 15, 1996 after a review of 162 days - an extended review 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: 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 W.L. Gore & Associates, Inc. devices

Submission Details

510(k) Number K955533 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received December 05, 1995
Decision Date May 15, 1996
Days to Decision 162 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
37d slower than avg
Panel avg: 125d · This submission: 162d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DYF Prosthesis, Vascular Graft, Of Less Then 6mm 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 - DYF Prosthesis, Vascular Graft, Of Less Then 6mm Diameter

All 14
Devices cleared under the same product code (DYF) and FDA review panel - the closest regulatory comparables to K955533.
ADVANTA GRAFT
K992441 · Atrium Medical Corp. · Aug 1999
PERMA-PASS VASCULAR GRAFT, 5T GRAFT,MODEL 31451
K984183 · Possis Medical, Inc. · Feb 1999
MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT
K960766 · Meadox Medicals, Div. Boston Scientific Corp. · Mar 1997
DIASTAT VASCULAR ACCESS GRAFT
K953287 · W.L. Gore & Associates, Inc. · Oct 1995
BAXTER REINFORCED EXPANDED PTFE STEPPED VASCULAR GRAFT
K944844 · Baxter Healthcare Corp · Mar 1995
ATRIUM'S HYBRID PTFE
K933391 · Atrium Medical Corp. · Dec 1994