Cleared Traditional

K873931 - MODIFIED MODELS 1025M & 1026T PACING LEAD

K873931 is the FDA 510(k) clearance for MODIFIED MODELS 1025M & 1026T PACING LEAD by Pacesetter Systems. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K873931 · Pacesetter Systems · Cardiovascular device
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Oct 1987
Decision
38d
Days
Class 3
Risk

K873931 is an FDA 510(k) clearance for the MODIFIED MODELS 1025M & 1026T PACING LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Pacesetter Systems (Sylmar, US). The FDA issued a Cleared decision on October 22, 1987 after a review of 38 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 K873931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1987
Decision Date October 22, 1987
Days to Decision 38 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
87d faster than avg
Panel avg: 125d · This submission: 38d
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 K873931.
MEDTRONIC PERMANENT LEAD INTRODUCER
K874167 · Medtronic Vascular · Dec 1987
MODEL 366-30 ADAPTAID(TM) ADAPTER SLEEVE
K873921 · Intermedics, Inc. · Dec 1987
MEDTRONIC MODEL 5513 ENDOCARDIAL PACING LEAD
K870885 · Medtronic Vascular · Nov 1987
PICF 0860/PSCF 0860/PSC 0860/PIAF 0860/PSAF 0860
K872731 · Ela Medical, Inc. · Sep 1987
SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438
K865098 · Telectronics, Inc. · Aug 1987
IMPLANTABLE PACING LEAD MODELS 487-06 TO 430-01
K871580 · Intermedics, Inc. · May 1987