Cleared Traditional

MODEL 430-05 POLYFLEX IMPLANTABLE PACING LEAD (K864287) - FDA 510(k) Clearance

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

K864287 · Intermedics, Inc. · Cardiovascular device

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Nov 1986

Decision

21d

Days

Class 3

Risk

K864287 is an FDA 510(k) clearance for the MODEL 430-05 POLYFLEX 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 November 20, 1986 after a review of 21 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	K864287 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 30, 1986
Decision Date	November 20, 1986
Days to Decision	21 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

104d faster than avg

Panel avg: 125d · This submission: 21d

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 K864287.

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

MODEL 431-06 POLYFLEX IMPLANTABLE PACING LEAD

K864002 · Intermedics, Inc. · Nov 1986

MODEL 493-08 POLYFLEX ENDOCARDIAL LEAD

K863781 · Intermedics, Inc. · Nov 1986

MODEL 366-28 ADAPTAID(TM) STEP-DOWN ADAPTER

K864047 · Intermedics, Inc. · Nov 1986

MODEL 366-27 ADAPTAID(TM) STEP-DOWN ADAPTER

K864048 · Intermedics, Inc. · Nov 1986

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K864287

Intermedics, Inc.

Freeport, TX · US

KEN BISHOP

Regulatory profile

211 submissions 201 cleared

95% clearance rate · Active in Cardiovascular

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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