Cleared Traditional

K944957 - TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500

K944957 is an FDA 510(k) clearance for TEMPORARY MYOCARDIAL PACING LEAD, manufactured by Medtronic Blood Systems, Inc.. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 280-day FDA review.

K944957 · Medtronic Blood Systems, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1995
Decision
280d
Days
Class 2
Risk

K944957 is an FDA 510(k) clearance for the TEMPORARY MYOCARDIAL PACING LEAD, MODEL 6500. Classified as Electrode, Pacemaker, Temporary (product code LDF), Class II - Special Controls.

Submitted by Medtronic Blood Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on July 14, 1995 after a review of 280 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 Medtronic Blood Systems, Inc. devices

FDA 510(k) Submission Details - K944957

510(k) Number K944957 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1994
Decision Date July 14, 1995
Days to Decision 280 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
155d slower than avg
Panel avg: 125d · This submission: 280d
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 93
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K944957.
FLEXON TEMPORARY CARDIAC PACER LEAD
K955722 · Davis & Geck, Inc. · Mar 1996
UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE MODEL 6494
K954809 · Medtronic Vascular · Dec 1995
MULTIPACE
K934785 · Electro-Catheter Corp. · Jul 1995
SILICORE SEMI-FLOATER
K934787 · Electro-Catheter Corp. · Feb 1995
BIPOLAR BALLOON PACING CATHETER BY J-LLOYD
K930069 · J-Lloyd Medical, Inc. · Jan 1994
UNIPOLAR ATRIAL TEMPORARY PACING LEAD, MODEL 6492
K922182 · Medtronic Vascular · Nov 1992