Cleared Traditional

K851913 - CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD...

K851913 is an FDA 510(k) clearance for CORDIS HIGH-TORQUE TEMP. PERVENOUS LEAD..., manufactured by Cordis Corp.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 138-day FDA review.

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

FDA 510(k) Submission Details - K851913

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.

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 82
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K851913.
TB SERIES BIPOLAR PACING LEADS
K861403 · Oscor Medical Corp. · Jun 1986
FLEXON TEMPORARY CARDIAC CONDUCTIVE MULTIFILAMENT
K855139 · Davis & Geck, Inc. · Feb 1986
MEDTRONIC MODEL 6405
K853818 · Medtronic Vascular · Oct 1985
115-GK BARD CARE TRANSLU VENTRICULAR PACING LEAD
K852513 · C.R. Bard, Inc. · Sep 1985
NUMED TEMP. STYLET PACING PAROBE 1318694
K851845 · NuMED, Inc. · Aug 1985
NUMED BALLOON PACING CATHETER
K851246 · NuMED, Inc. · Apr 1985