Cleared Traditional

K963898 - MODEL 6495 BIPOLAR TEMPORARY PACING LEAD

K963898 is an FDA 510(k) clearance for MODEL 6495 BIPOLAR TEMPORARY PACING LEAD, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code LDF cleared through the Traditional 510(k) pathway after a 298-day FDA review.

K963898 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1997
Decision
298d
Days
Class 2
Risk

K963898 is an FDA 510(k) clearance for the MODEL 6495 BIPOLAR TEMPORARY PACING LEAD. 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 July 22, 1997 after a review of 298 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 Vascular devices

FDA 510(k) Submission Details - K963898

510(k) Number K963898 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 1996
Decision Date July 22, 1997
Days to Decision 298 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
173d slower than avg
Panel avg: 125d · This submission: 298d
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 92
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K963898.
HARMAC TEMPORARY PACING CATHETER WITH BALLOON
K962833 · Harmac Medical Products, Inc. · Oct 1997
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
K963073 · Harmac Medical Products, Inc. · Aug 1997
INTRODUCER SHEATH AND DILATOR
K971165 · Boston Scientific Corp · Jul 1997
UNIPOLAR IPG GROUND CABLE, MODEL 5473
K961520 · Medtronic Vascular · Nov 1996
ARROW BIPOLAR PACING/BALLOON WEDGE PRESSURE CATHETER
K960479 · Arrow Intl., Inc. · Oct 1996
USCI BIPOLAR BALLOON PACING ELECTRODE WITH BH COATING
K955712 · C.R. Bard, Inc. · Oct 1996