Cleared Traditional

LIFELINE TLE 484-02 (K843394) - FDA 510(k) Clearance

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

K843394 · Intermedics, Inc. · Cardiovascular device
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Sep 1984
Decision
26d
Days
Class 3
Risk

K843394 is an FDA 510(k) clearance for the LIFELINE TLE 484-02. 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 September 24, 1984 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 Intermedics, Inc. devices

Submission Details

510(k) Number K843394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 1984
Decision Date September 24, 1984
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 221
Devices cleared under the same product code (DTB) and FDA review panel - the closest regulatory comparables to K843394.
CORDIS ENCOR ATRIAL LEAD
K811259 · Cordis Corp. · Dec 1984
MEDTRONIC 6957
K843706 · Medtronic Vascular · Dec 1984
LIFELINE TLE 476-04
K843393 · Intermedics, Inc. · Sep 1984
ELECTRODE LEAD CONSTRUCTION
K834533 · Telectronics, Inc. · Jan 1984
ELECTRODE LEADS 030-267 & 030-268
K832110 · Telectronics, Inc. · Aug 1983
LIFELINE PACING LEADS #471-07 &09
K832409 · Intermedics, Inc. · Aug 1983