Cleared Traditional

K864155 - MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS (FDA 510(k) Clearance)

Class I Cardiovascular device.

K864155 · American Edwards Laboratories · Cardiovascular device
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Nov 1986
Decision
28d
Days
Class 1
Risk

K864155 is an FDA 510(k) clearance for the MODIFICATION OF CARPENTIER-EDWARDS BIOPROSTHESIS. Classified as Holder, Heart-valve, Prosthesis (product code DTJ), Class I - General Controls.

Submitted by American Edwards Laboratories (Santa Ana, US). The FDA issued a Cleared decision on November 20, 1986 after a review of 28 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3935 - 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 American Edwards Laboratories devices

Submission Details

510(k) Number K864155 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1986
Decision Date November 20, 1986
Days to Decision 28 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTJ Holder, Heart-valve, Prosthesis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.3935
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.