Cleared Traditional

SYMMETRY AORTIC CLIP SYSTEM (K003446) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K003446 · St. Jude Medical Cardiovascular Group, Inc. · General & Plastic Surgery device
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May 2001
Decision
196d
Days
Class 2
Risk

K003446 is an FDA 510(k) clearance for the SYMMETRY AORTIC CLIP SYSTEM. Classified as Clip, Implantable, For Coronary Artery Bypass Graft (cabg) (product code NCA), Class II - Special Controls.

Submitted by St. Jude Medical Cardiovascular Group, Inc. (Rockville, US). The FDA issued a Cleared decision on May 21, 2001 after a review of 196 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4300 - the FDA general and plastic surgery device 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all St. Jude Medical Cardiovascular Group, Inc. devices

Submission Details

510(k) Number K003446 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 2000
Decision Date May 21, 2001
Days to Decision 196 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
81d slower than avg
Panel avg: 115d · This submission: 196d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NCA Clip, Implantable, For Coronary Artery Bypass Graft (cabg)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4300
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 General & Plastic Surgery devices follow this clearance model.