Cleared Traditional

K862443 - MEDTRONIC TEMPORARY AND IMPLANTABLE PAC...

K862443 is the FDA 510(k) clearance for MEDTRONIC TEMPORARY AND IMPLANTABLE PAC... by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DTB) cleared through the Traditional 510(k) pathway after a 14-day FDA review.

K862443 · Medtronic Vascular · Cardiovascular device
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Jul 1986
Decision
14d
Days
Class 3
Risk

K862443 is an FDA 510(k) clearance for the MEDTRONIC TEMPORARY AND IMPLANTABLE PACING LEADS. 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 July 10, 1986 after a review of 14 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 K862443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1986
Decision Date July 10, 1986
Days to Decision 14 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
111d faster than avg
Panel avg: 125d · This submission: 14d
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 K862443.
MODEL 431-02 BIOPORE IMPLANTABLE PACING LEAD
K862257 · Intermedics, Inc. · Jul 1986
MODEL 437-01 BIOPORE IMPLANTABLE PACING LEAD
K862258 · Intermedics, Inc. · Jul 1986
MODEL 433-01 BIOPORE IMPLANTABLE PACING LEAD
K862259 · Intermedics, Inc. · Jul 1986
MODEL 438-01 CARDIFIX IMPLANTABLE PACING LEAD
K862052 · Intermedics, Inc. · Jul 1986
MODEL 435-02 CARDIFIX IMPLANTABLE PACING LEAD
K862276 · Intermedics, Inc. · Jul 1986
CORDIS HI-FLEX PERVENOUS BIPOLAR LEAD
K860846 · Cordis Corp. · Jun 1986