Cleared Traditional

K951368 - CARBOMEDICS EXENDED MITRAL ROTATOR (FDA 510(k) Clearance)

Class I Cardiovascular device.

K951368 · Carbomedics, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 1995
Decision
85d
Days
Class 1
Risk

K951368 is an FDA 510(k) clearance for the CARBOMEDICS EXENDED MITRAL ROTATOR. Classified as Rotator, Prosthetic Heart Valve (product code MOP), Class I - General Controls.

Submitted by Carbomedics, Inc. (Austin, US). The FDA issued a Cleared decision on June 20, 1995 after a review of 85 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 Carbomedics, Inc. devices

Submission Details

510(k) Number K951368 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 1995
Decision Date June 20, 1995
Days to Decision 85 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MOP Rotator, Prosthetic Heart Valve
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.