Cleared Traditional

K893471 - MEDTRONIC MODEL 9444 TELETRACE II ECG M...

K893471 is the FDA 510(k) clearance for MEDTRONIC MODEL 9444 TELETRACE II ECG M... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DXH) cleared through the Traditional 510(k) pathway after a 145-day FDA review.

K893471 · Medtronic Vascular · Cardiovascular device
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Sep 1989
Decision
145d
Days
Class 2
Risk

K893471 is an FDA 510(k) clearance for the MEDTRONIC MODEL 9444 TELETRACE II ECG MONITORING. Classified as Transmitters And Receivers, Electrocardiograph, Telephone (product code DXH), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on September 26, 1989 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2920 - 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 Medtronic Vascular devices

Submission Details

510(k) Number K893471 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1989
Decision Date September 26, 1989
Days to Decision 145 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
20d slower than avg
Panel avg: 125d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DXH Transmitters And Receivers, Electrocardiograph, Telephone
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2920
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 - DXH Transmitters And Receivers, Electrocardiograph, Telephone

All 92
Devices cleared under the same product code (DXH) and FDA review panel - the closest regulatory comparables to K893471.
PDT CARRYALL TRANSMITTER, VARIOUS MODELS
K912379 · Cardiac Pacemakers, Inc. · Jun 1991
MODEL 9444 TELETRACE II ECG MONITORING SYSTEM
K903960 · Medtronic Vascular · Oct 1990
TELEMETRY RECEIVER ACCESSORY FOR THE CMS 8000
K894540 · Physio-Control Corp. · Oct 1989
M1400A TRANSMITTER,M1402 RECEIVER,M1401 MAINFRAME
K894277 · Hewlett-Packard Co. · Sep 1989
MEDTRONIC MODEL 9443 IN-OFFICE TRANSMITTER
K894140 · Medtronic Vascular · Jul 1989
CARD GUARD, MODEL CG-2000
K882290 · Card Guard Scientific Survival , Ltd. · Jul 1988