Cleared Traditional

K954809 - UNIPOLAR TEMPORARY MYOCARDIAL PACING WI...

K954809 is the FDA 510(k) clearance for UNIPOLAR TEMPORARY MYOCARDIAL PACING WI... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 55-day FDA review.

K954809 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1995
Decision
55d
Days
Class 2
Risk

K954809 is an FDA 510(k) clearance for the UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on December 13, 1995 after a review of 55 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Medtronic Vascular devices

Submission Details

510(k) Number K954809 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1995
Decision Date December 13, 1995
Days to Decision 55 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 125d · This submission: 55d
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 77
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K954809.
USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING
K955712 · C.R. Bard, Inc. · Oct 1996
RV PACING LEAD
K962467 · Abbott Laboratories · Sep 1996
FLEXON TEMPORARY CARDIAC PACER LEAD
K955722 · Davis & Geck, Inc. · Mar 1996
MULTIPACE
K934785 · Electro-Catheter Corp. · Jul 1995
SILICORE SEMI-FLOATER
K934787 · Electro-Catheter Corp. · Feb 1995
UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
K922182 · Medtronic Vascular · Nov 1992