Cleared Traditional

K831436 - UNIPOLAR ATRIAL J PACING LEAD MODEL 869

K831436 is the FDA 510(k) clearance for UNIPOLAR ATRIAL J PACING LEAD MODEL 869 by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K831436 · Pacesetter Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1983
Decision
35d
Days
Class 3
Risk

K831436 is an FDA 510(k) clearance for the UNIPOLAR ATRIAL J PACING LEAD MODEL 869. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Mchenry, US). The FDA issued a Cleared decision on June 8, 1983 after a review of 35 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 Pacesetter Systems devices

Submission Details

510(k) Number K831436 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1983
Decision Date June 08, 1983
Days to Decision 35 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
90d faster than avg
Panel avg: 125d · This submission: 35d
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 K831436.
IMPLANTABLE CARDIAC PACING LEADS
K831767 · Oscor, Inc. · Jul 1983
MEDTRONIC MODELS 4012 & 4512
K832099 · Medtronic Vascular · Jul 1983
VENTRICULAR PACING LEADS MODELS 865/867
K831435 · Pacesetter Systems · Jun 1983
POROUS TIP ENDOCARDIAL LEAD
K830743 · Daig Corp. · May 1983
MODEL JY PACEMAKER LEAD - VARIOUS
K823889 · Oscor, Inc. · Apr 1983
MODEL MZ PACEMAKER LEAD-VARIOUS
K823893 · Oscor, Inc. · Apr 1983