Cleared Traditional

SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T (K930876) - FDA 510(k) Clearance

Class III device cleared through the 510(k) pathway via substantial equivalence to a legally marketed predicate.

K930876 · Siemens-Pacesetter, Inc. · Cardiovascular device
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Jun 1994
Decision
481d
Days
Class 3
Risk

K930876 is an FDA 510(k) clearance for the SILICONE BIPOLAR LEAD MODELS 1136T, 1142T &1146T. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Siemens-Pacesetter, Inc. (Sylmar, US). The FDA issued a Cleared decision on June 15, 1994 after a review of 481 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. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Siemens-Pacesetter, Inc. devices

Submission Details

510(k) Number K930876 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received February 19, 1993
Decision Date June 15, 1994
Days to Decision 481 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
356d slower than avg
Panel avg: 125d · This submission: 481d
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 187
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K930876.
MODELS 5866-45 AND 5866-46 SIZING SLEEVE
K954085 · Medtronic Vascular · Nov 1995
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS
K951858 · Medtronic Vascular · Oct 1995
MEDTRONIC MODEL 4558M
K940703 · Medtronic Vascular · Nov 1994
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