Cleared Special

K031274 - MODEL 5071 MYOCARDIAL PACING LEAD (FDA 510(k) Clearance)

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

K031274 · Medtronic Vascular · Cardiovascular device
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May 2003
Decision
30d
Days
Class 3
Risk

K031274 is an FDA 510(k) clearance for the MODEL 5071 MYOCARDIAL PACING LEAD. 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 May 22, 2003 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3680 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

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 K031274 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received April 22, 2003
Decision Date May 22, 2003
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

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.