Cleared Traditional

POLYFLEX IMPLANTABLE PACING LEAD (K802293) - FDA 510(k) Clearance

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

K802293 · Intermedics, Inc. · Cardiovascular device
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Oct 1980
Decision
42d
Days
Class 3
Risk

K802293 is an FDA 510(k) clearance for the POLYFLEX IMPLANTABLE PACING LEAD. Classified as Permanent Pacemaker Electrode (product code DTB), Class III - Premarket Approval.

Submitted by Intermedics, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 31, 1980 after a review of 42 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 K802293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 1980
Decision Date October 31, 1980
Days to Decision 42 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
83d faster than avg
Panel avg: 125d · This submission: 42d
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 K802293.
INTERMEDICS' LIFELINE TLE ENDOCARDIAL
K801172 · Intermedics, Inc. · Dec 1980
LOW PROFILE LEAD CONNECTOR MODIFICATION (4002)
K801284 · Medtronic Vascular · Dec 1980
MEDTRONIC MODEL 6958
K800870 · Medtronic Vascular · Nov 1980
IMPLANTABLE ENDOCARDIAL POROUS TIP ELEC.
K801792 · Telectronics, Inc. · Oct 1980
MEDTRONIC MODEL 69575
K800944 · Medtronic Vascular · Sep 1980
LIFELINE TLE (TRAEBECULAR LODGING ELEC
K792300 · Intermedics, Inc. · Jun 1980