Cleared Traditional

DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER (K890794) - FDA 510(k) Clearance

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

K890794 · Daig Corp. · Cardiovascular device
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Jun 1989
Decision
123d
Days
Class 2
Risk

K890794 is an FDA 510(k) clearance for the DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Daig Corp. (Minnetonka, US). The FDA issued a Cleared decision on June 20, 1989 after a review of 123 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 Daig Corp. devices

Submission Details

510(k) Number K890794 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1989
Decision Date June 20, 1989
Days to Decision 123 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
2d faster than avg
Panel avg: 125d · This submission: 123d
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 47
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K890794.
MEDTRONIC MODELS 5455L AND 5455SL SURGICAL CABLES
K923407 · Medtronic Vascular · Oct 1992
UNIPOLAR PEDIATRIC TEMPORARY PACING LEAD, #6491
K902342 · Medtronic Vascular · Oct 1990
UNIPOLAR TEMP. MYOCARDIAL HEART WIRE, MODEL 6490
K895789 · Medtronic Vascular · Dec 1989
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