Cleared Traditional

IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY (K960281) - FDA 510(k) Clearance

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

K960281 · Intermedics, Inc. · Cardiovascular device
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Jun 1996
Decision
151d
Days
Class 3
Risk

K960281 is an FDA 510(k) clearance for the IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Angleton, US). The FDA issued a Cleared decision on June 18, 1996 after a review of 151 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 Intermedics, Inc. devices

Submission Details

510(k) Number K960281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Third Party Review (ST)
Date Received January 19, 1996
Decision Date June 18, 1996
Days to Decision 151 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
26d slower than avg
Panel avg: 125d · This submission: 151d
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 221
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K960281.
MODEL 2188 CORONARY SINUS LEAD.
K961936 · Medtronic Vascular · Aug 1996
TRANSVENOUS, PERMANENT TINED TARGET TIP PACING LEADS/TRANSVENOUS, PERMANENT SCREW-IN PACING LEADS
K961679 · Medtronic Vascular · Jul 1996
CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD
K955550 · Intermedics, Inc. · Jun 1996
INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD
K954719 · Intermedics, Inc. · Feb 1996
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