Cleared Traditional

K853398 - MEDTRONIC MODEL 5062 (FDA 510(k) Clearance)

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K853398 · Medtronic Vascular · Cardiovascular device
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Dec 1985
Decision
114d
Days
Class 3
Risk

K853398 is an FDA 510(k) clearance for the MEDTRONIC MODEL 5062. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 4, 1985 after a review of 114 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - 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: High-complexity regulatory submission. High regulatory complexity profile. 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 K853398 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 12, 1985
Decision Date December 04, 1985
Days to Decision 114 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DTB Permanent Pacemaker Electrode
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3680
What this classification means

Class III devices typically require Premarket Approval (PMA) with clinical evidence. Clearance through 510(k) for Class III devices is granted only when substantial equivalence to a valid predicate can be established.