Cleared Traditional

MITRAL VALVE ORIFICE SIZER (K820887) - FDA 510(k) Clearance

Class I Cardiovascular device.

K820887 · Celtech · Cardiovascular device
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Jul 1982
Decision
100d
Days
Class 1
Risk

K820887 is an FDA 510(k) clearance for the MITRAL VALVE ORIFICE SIZER. Classified as Sizer, Heart-valve, Prosthesis (product code DTI), Class I - General Controls.

Submitted by Celtech (Mchenry, US). The FDA issued a Cleared decision on July 8, 1982 after a review of 100 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3945 - 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 K820887 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 30, 1982
Decision Date July 08, 1982
Days to Decision 100 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 125d · This submission: 100d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTI Sizer, Heart-valve, Prosthesis
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.3945
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.