Cleared Traditional

K960766 - MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K960766 · Meadox Medicals, Div. Boston Scientific Corp. · Cardiovascular device
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Mar 1997
Decision
387d
Days
Class 2
Risk

K960766 is an FDA 510(k) clearance for the MEADOX MEDICALS, INC. EXPANDED PTFE VASCULAR GRAFT. Classified as Prosthesis, Vascular Graft, Of Less Then 6mm Diameter (product code DYF), Class II - Special Controls.

Submitted by Meadox Medicals, Div. Boston Scientific Corp. (Oakland, US). The FDA issued a Cleared decision on March 19, 1997 after a review of 387 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Meadox Medicals, Div. Boston Scientific Corp. devices

Submission Details

510(k) Number K960766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received February 26, 1996
Decision Date March 19, 1997
Days to Decision 387 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
262d slower than avg
Panel avg: 125d · This submission: 387d
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.