Cleared Traditional

K890988 - MODEL 3110 HEART WIRE & 3110P PEDIATRIC...

K890988 is the FDA 510(k) clearance for MODEL 3110 HEART WIRE & 3110P PEDIATRIC... by Pace Medical. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 179-day FDA review.

K890988 · Pace Medical · Cardiovascular device
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Aug 1989
Decision
179d
Days
Class 2
Risk

K890988 is an FDA 510(k) clearance for the MODEL 3110 HEART WIRE & 3110P PEDIATRIC HEART WIRE. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Pace Medical (Waltham, US). The FDA issued a Cleared decision on August 25, 1989 after a review of 179 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 Pace Medical devices

Submission Details

510(k) Number K890988 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 27, 1989
Decision Date August 25, 1989
Days to Decision 179 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d slower than avg
Panel avg: 125d · This submission: 179d
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 78
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K890988.
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
BARD BAIM-TURI BALLOON DIAGNOSTIC PACING CATHETER
K882330 · C.R. Bard, Inc. · Sep 1988
DISPOSABLE BIPOLAR TEMPORARY PACING ELECTRODE
K875059 · Daig Corp. · Feb 1988