Cleared Traditional

K904868 - XEMEX TEMPORARY PACING CATHETER A

K904868 is an FDA 510(k) clearance for XEMEX TEMPORARY PACING CATHETER A, manufactured by Zeon Medical Corp.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 199-day FDA review.

K904868 · Zeon Medical Corp. · Cardiovascular device
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May 1991
Decision
199d
Days
Class 2
Risk

K904868 is an FDA 510(k) clearance for the XEMEX TEMPORARY PACING CATHETER A. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Zeon Medical Corp. (White Plains, US). The FDA issued a Cleared decision on May 16, 1991 after a review of 199 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 Zeon Medical Corp. devices

FDA 510(k) Submission Details - K904868

510(k) Number K904868 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1990
Decision Date May 16, 1991
Days to Decision 199 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d slower than avg
Panel avg: 125d · This submission: 199d
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 K904868.
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD MOD. 6491
K922268 · Medtronic Vascular · Nov 1992
MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
K923407 · Medtronic Vascular · Oct 1992
PACEL(TM) FLOW DIRECTED PACING CATHETER
K914185 · Daig Corp. · Jan 1992
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
K902342 · Medtronic Vascular · Oct 1990
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
K895789 · Medtronic Vascular · Dec 1989
DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER
K890794 · Daig Corp. · Jun 1989