Cleared Traditional

MYOWIRE-ATEMPORARY CARDIAC PACING WIRE (K803086) - FDA 510(k) Clearance

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

K803086 · Craig & Craig, Inc. · Cardiovascular device
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Jul 1981
Decision
205d
Days
Class 2
Risk

K803086 is an FDA 510(k) clearance for the MYOWIRE-ATEMPORARY CARDIAC PACING WIRE. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Craig & Craig, Inc. (Walker, US). The FDA issued a Cleared decision on July 1, 1981 after a review of 205 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 Craig & Craig, Inc. devices

Submission Details

510(k) Number K803086 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1980
Decision Date July 01, 1981
Days to Decision 205 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d slower than avg
Panel avg: 125d · This submission: 205d
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 K803086.
TEMPORARY PERVENOUS J-ATRIAL LEAD
K812781 · Cordis Corp. · Oct 1981
USCI TRANSTHORACIC TEMP. PACING ELECTROD
K812307 · C.R. Bard, Inc. · Sep 1981
TEMPORARY ENDOCARDIAL TRIPOLAR LD. #6880
K811318 · Medtronic Vascular · Jul 1981
TEMPTRON #'S 6804/6805
K810657 · Medtronic Vascular · Apr 1981
CORDIS TEMPORATY CURVED ATRIAL LEAD
K810041 · Cordis Corp. · Feb 1981
USCI BIPOLAR BALLON PACING ELECTRODE
K800298 · C.R. Bard, Inc. · Apr 1980