Cleared Traditional

CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA (K851913) - FDA 510(k) Clearance

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

K851913 · Cordis Corp. · Cardiovascular device
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Sep 1985
Decision
138d
Days
Class 2
Risk

K851913 is an FDA 510(k) clearance for the CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD W/DEPTH MA. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Cordis Corp. (Miami, US). The FDA issued a Cleared decision on September 16, 1985 after a review of 138 days - within the typical 510(k) review window.

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 Cordis Corp. devices

Submission Details

510(k) Number K851913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 01, 1985
Decision Date September 16, 1985
Days to Decision 138 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
13d slower than avg
Panel avg: 125d · This submission: 138d
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 K851913.
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330 · C.R. Bard, Inc. · Sep 1988
TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500
K862970 · Medtronic Vascular · Sep 1987
MEDTRONIC MODEL 6405
K853818 · Medtronic Vascular · Oct 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