Cleared Traditional

K862459 - MODIFIED CIRCUIT BURN-IN PROCESS IMPLAN...

K862459 is the FDA 510(k) clearance for MODIFIED CIRCUIT BURN-IN PROCESS IMPLAN... by Medtronic Vascular. It is a Class 3 Cardiovascular device (product code DXY) cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K862459 · Medtronic Vascular · Cardiovascular device
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Jan 1987
Decision
186d
Days
Class 3
Risk

K862459 is an FDA 510(k) clearance for the MODIFIED CIRCUIT BURN-IN PROCESS IMPLANTABLE PULSE. Classified as Implantable Pacemaker Pulse-generator (product code DXY), Class III - Premarket Approval.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on January 2, 1987 after a review of 186 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3610 - 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 K862459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 1986
Decision Date January 02, 1987
Days to Decision 186 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
61d slower than avg
Panel avg: 125d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DXY Implantable Pacemaker Pulse-generator
Device Class Class 3 - Premarket Approval
CFR Regulation 21 CFR 870.3610
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 - DXY Implantable Pacemaker Pulse-generator

All 338
Devices cleared under the same product code (DXY) and FDA review panel - the closest regulatory comparables to K862459.
MULTILITH 3 MODELS 1350, 3350, 1370, 3370
K863898 · Ela Medical, Inc. · Feb 1987
DIALOG MODELS 748, 748K AND 748T PULSE GENERATORS
K862226 · Pacesetter Systems · Feb 1987
EDP-20 PACEMAKER
K860036 · Biotronik Sales, Inc. · Jan 1987
TRIOS-M VS-1 PULSE GENERATOR
K863878 · Biotronik Sales, Inc. · Dec 1986
NEOS-M VS-1 PULSE GENERATOR
K863879 · Biotronik Sales, Inc. · Dec 1986
CORDIS MULTICOR II MODEL 402D PACER
K863417 · Cordis Corp. · Oct 1986