Cleared Traditional

MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD (K862276) - FDA 510(k) Clearance

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

K862276 · Intermedics, Inc. · Cardiovascular device
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Jul 1986
Decision
16d
Days
Class 3
Risk

K862276 is an FDA 510(k) clearance for the MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Freeport, US). The FDA issued a Cleared decision on July 2, 1986 after a review of 16 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 Intermedics, Inc. devices

Submission Details

510(k) Number K862276 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 1986
Decision Date July 02, 1986
Days to Decision 16 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
109d faster than avg
Panel avg: 125d · This submission: 16d
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 K862276.
MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD
K862259 · Intermedics, Inc. · Jul 1986
MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS
K862443 · Medtronic Vascular · Jul 1986
MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD
K862052 · Intermedics, Inc. · Jul 1986
CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD
K860846 · Cordis Corp. · Jun 1986
MODEL 486-02 ENDOCARDIAL PACING LEAD
K860547 · Intermedics, Inc. · Jun 1986
MODEL 492-02 ENDOCARDIAL PACING LEAD
K860548 · Intermedics, Inc. · Jun 1986