Cleared Traditional

ELECATH HEPARIN COATED TEMP. PACING (K840109) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K840109 · Electro-Catheter Corp. · Cardiovascular device
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Feb 1984
Decision
25d
Days
Class 2
Risk

K840109 is an FDA 510(k) clearance for the ELECATH HEPARIN COATED TEMP. PACING. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Electro-Catheter Corp. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 25 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Electro-Catheter Corp. devices

Submission Details

510(k) Number K840109 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1984
Decision Date February 04, 1984
Days to Decision 25 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 125d · This submission: 25d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LDF Electrode, Pacemaker, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3680
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - LDF Electrode, Pacemaker, Temporary

All 50
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K840109.
CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA
K851913 · Cordis Corp. · Sep 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513 · C.R. Bard, Inc. · Sep 1985
LUMELEC ELECTRODE CATHETER
K834416 · Cordis Corp. · Apr 1984
EPCOR MULTIELECTRODE TEMP. PERVENOUS
K832561 · Cordis Corp. · Oct 1983
USCI TEMP. ATRIO-VENTRICULAR ELECTRODE
K830094 · C.R. Bard, Inc. · Feb 1983
ETHICON* TEMP. CARDIAC PACING WIRE
K813138 · Ethicon, Inc. · Dec 1981