Cleared Traditional

K915736 - MEDTRONIC MODELS 5069 AND 5071 MYOCARDI...

K915736 is the FDA 510(k) clearance for MEDTRONIC MODELS 5069 AND 5071 MYOCARDI... by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 349-day FDA review.

K915736 · Medtronic Vascular · Cardiovascular device
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Dec 1992
Decision
349d
Days
Class 3
Risk

K915736 is an FDA 510(k) clearance for the MEDTRONIC MODELS 5069 AND 5071 MYOCARDIAL PACING. 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 3, 1992 after a review of 349 days - an unusually long review period, suggesting complex equivalence evaluation.

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 K915736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Product Development Protocol (SESP)
Date Received December 20, 1991
Decision Date December 03, 1992
Days to Decision 349 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
224d slower than avg
Panel avg: 125d · This submission: 349d
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.

Regulatory Peers - DTB Permanent Pacemaker Electrode

All 364
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K915736.
POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA
K925099 · Possis Medical, Inc. · Jun 1993
CARDIFIX ENDOCARDIAL PACING LEAD
K922042 · Intermedics, Inc. · Apr 1993
MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD
K922972 · Intermedics, Inc. · Jan 1993
MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD
K915188 · Cook Pacemaker Corp. · Sep 1992
MODELS 6917T, 6917AT & 4951M EPICARDIAL PACE LEADS
K921124 · Medtronic Vascular · May 1992
PERMANENT CARDIAC PACING LEADS AND ADAPTORS
K912464 · Medtronic Vascular · Feb 1992