Cleared Traditional

K864856 - MODEL 5866-24 PACEMAKER LEAD ADAPTOR

K864856 is the FDA 510(k) clearance for MODEL 5866-24 PACEMAKER LEAD ADAPTOR by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K864856 · Medtronic Vascular · Cardiovascular device
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Jan 1987
Decision
26d
Days
Class 3
Risk

K864856 is an FDA 510(k) clearance for the MODEL 5866-24 PACEMAKER LEAD ADAPTOR. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 6, 1987 after a review of 26 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 Medtronic Vascular devices

Submission Details

510(k) Number K864856 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 11, 1986
Decision Date January 06, 1987
Days to Decision 26 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
99d faster than avg
Panel avg: 125d · This submission: 26d
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 K864856.
MEDTRONIC MODEL 5013
K863536 · Medtronic Vascular · Jan 1987
ANCOR PERVENOUS ACTIVE FIXATION UNIPOLAR LEAD
K864640 · Cordis Corp. · Jan 1987
MODEL 366-14 INTERMEDICS LEAD CONNECTOR CAP
K864738 · Intermedics, Inc. · Jan 1987
TELECTRONICS SREW-IN/SLIM LINE PACING LEADS
K864098 · Daig Corp. · Dec 1986
MODEL 366-23 ADAPTAID(TM) STEP-DOWN ADAPTER
K864428 · Intermedics, Inc. · Dec 1986
MODEL 486-05 POLYFLEX(R) IMPLANTABLE PACING LEAD
K864564 · Intermedics, Inc. · Dec 1986