Cleared Traditional

CORONARY VEIN GRAFT TAG MARKER (K971966) - FDA 510(k) Clearance

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

K971966 · Med-Edge, Inc. · Cardiovascular device
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Jan 1998
Decision
243d
Days
Class 2
Risk

K971966 is an FDA 510(k) clearance for the CORONARY VEIN GRAFT TAG MARKER. Classified as Marker, Ostia, Aorto-saphenous Vein (product code KPK), Class II - Special Controls.

Submitted by Med-Edge, Inc. (Clemmons, US). The FDA issued a Cleared decision on January 26, 1998 after a review of 243 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 878.4650 - 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.

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Submission Details

510(k) Number K971966 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1997
Decision Date January 26, 1998
Days to Decision 243 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
118d slower than avg
Panel avg: 125d · This submission: 243d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPK Marker, Ostia, Aorto-saphenous Vein
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4650
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.