Cleared Traditional

K852612 - METRONIC MODEL F7700 HEART VALVE SIZERS (FDA 510(k) Clearance)

Class I Cardiovascular device.

K852612 · Medtronic Vascular · Cardiovascular device
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Sep 1985
Decision
96d
Days
Class 1
Risk

K852612 is an FDA 510(k) clearance for the METRONIC MODEL F7700 HEART VALVE SIZERS. Classified as Sizer, Heart-valve, Prosthesis (product code DTI), Class I - General Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on September 23, 1985 after a review of 96 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.

View all Medtronic Vascular devices

Submission Details

510(k) Number K852612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 1985
Decision Date September 23, 1985
Days to Decision 96 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 125d · This submission: 96d
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.