Cleared Traditional

K832099 - MEDTRONIC MODELS 4012 & 4512

K832099 is the FDA 510(k) clearance for MEDTRONIC MODELS 4012 & 4512 by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K832099 · Medtronic Vascular · Cardiovascular device
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Jul 1983
Decision
27d
Days
Class 3
Risk

K832099 is an FDA 510(k) clearance for the MEDTRONIC MODELS 4012 & 4512. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 27 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. 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 K832099 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 29, 1983
Decision Date July 26, 1983
Days to Decision 27 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 125d · This submission: 27d
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 K832099.
MODEL F UNIPOLAR ENDOCARDIAL LEAD-
K832255 · Cook Pacemaker Corp. · Aug 1983
LIFELINE PACING LEADS #471-07 &09
K832409 · Intermedics, Inc. · Aug 1983
IMPLANTABLE CARDIAC PACING LEADS
K831767 · Oscor, Inc. · Jul 1983
VENTRICULAR PACING LEADS MODELS 865/867
K831435 · Pacesetter Systems · Jun 1983
UNIPOLAR ATRIAL J PACING LEAD MODEL 869
K831436 · Pacesetter Systems · Jun 1983
POROUS TIP ENDOCARDIAL LEAD
K830743 · Daig Corp. · May 1983