Cleared Traditional

K931411 - MEDTRONIC MODEL 4081

K931411 is the FDA 510(k) clearance for MEDTRONIC MODEL 4081 by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K931411 · Medtronic Vascular · Cardiovascular device
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Sep 1993
Decision
188d
Days
Class 3
Risk

K931411 is an FDA 510(k) clearance for the MEDTRONIC MODEL 4081,4581,4582 TARGET TIP PACING L. 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 September 23, 1993 after a review of 188 days - an extended review cycle.

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 K931411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 1993
Decision Date September 23, 1993
Days to Decision 188 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
63d slower than avg
Panel avg: 125d · This submission: 188d
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 K931411.
MEDTRONIS(R) PACING LEADS AND LEAD ADAPTORS, MODIF
K933055 · Medtronic Vascular · May 1994
MEDTRONIC MODEL 5028 TARGET TIP, BIPOLAR, IMPLANTABLE, TINED, VENTRICULAR, TRANSVENOUS LEAD
K933731 · Medtronic Vascular · Mar 1994
MEDTRONIC MODELS 4057M,4058M,4557M, PACING LEADS
K932172 · Medtronic Vascular · Dec 1993
MAXIMA FILTERED HARDSHELL RESERVOIR
K932254 · Medtronic Vascular · Aug 1993
POSSIS MEDICAL MYOPORE BIPOLAR SUTURELESS MYCARDIA
K925099 · Possis Medical, Inc. · Jun 1993
CARDIFIX ENDOCARDIAL PACING LEAD
K922042 · Intermedics, Inc. · Apr 1993