Cleared Traditional

ELECTRODE CATHETER, ORTHOGONAL TYPE (K841802) - FDA 510(k) Clearance

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

K841802 · Webster Laboratories, Inc. · Cardiovascular device
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Oct 1984
Decision
170d
Days
Class 2
Risk

K841802 is an FDA 510(k) clearance for the ELECTRODE CATHETER, ORTHOGONAL TYPE. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Webster Laboratories, Inc. (Altadena, US). The FDA issued a Cleared decision on October 18, 1984 after a review of 170 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Webster Laboratories, Inc. devices

Submission Details

510(k) Number K841802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1984
Decision Date October 18, 1984
Days to Decision 170 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 125d · This submission: 170d
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 K841802.
MEDTRONIC MODEL 6405
K853818 · Medtronic Vascular · Oct 1985
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