Cleared Traditional

K831645 - TEMP. BIPOLAR EPICARDIAL LEAD

K831645 is an FDA 510(k) clearance for TEMP. BIPOLAR EPICARDIAL LEAD, manufactured by Cordic Corp.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K831645 · Cordic Corp. · Cardiovascular device
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Jul 1983
Decision
64d
Days
Class 2
Risk

K831645 is an FDA 510(k) clearance for the TEMP. BIPOLAR EPICARDIAL LEAD. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Cordic Corp. (Mchenry, US). The FDA issued a Cleared decision on July 26, 1983 after a review of 64 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 Cordic Corp. devices

FDA 510(k) Submission Details - K831645

510(k) Number K831645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 1983
Decision Date July 26, 1983
Days to Decision 64 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 125d · This submission: 64d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LDF Device Classification - Class 2, Special Controls

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 98
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K831645.
MULTIPOLAR TEMPORARY CARDIAC
K831804 · Oscor, Inc. · Oct 1983
EPCOR MULTIELECTRODE TEMP. PERVENOUS
K832561 · Cordis Corp. · Oct 1983
ELECATH PACEWEDGE DUAL PRESS. BIPOLAR
K832850 · Electro-Catheter Corp. · Oct 1983
TEMP. PACING LEAD, BIPOLAR #TH60, 90/110
K830772 · Oscor, Inc. · Apr 1983
USCI TEMP. ATRIO-VENTRICULAR ELECTRODE
K830094 · C.R. Bard, Inc. · Feb 1983
TRANSLUMINAL BIPOLAR PACING PROBE
K813521 · American Edwards Laboratories · Mar 1982