Cleared Traditional

K961520 - UNIPOLAR IPG GROUND CABLE, MODEL 5473

K961520 is an FDA 510(k) clearance for UNIPOLAR IPG GROUND CABLE, 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 205-day FDA review.

K961520 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1996
Decision
205d
Days
Class 2
Risk

K961520 is an FDA 510(k) clearance for the UNIPOLAR IPG GROUND CABLE, MODEL 5473. 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 November 13, 1996 after a review of 205 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 - K961520

510(k) Number K961520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1996
Decision Date November 13, 1996
Days to Decision 205 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
80d slower than avg
Panel avg: 125d · This submission: 205d
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 K961520.
HARMAC BIPOLAR TEMPORARY PACING CATHETER WITH STYLET
K963073 · Harmac Medical Products, Inc. · Aug 1997
INTRODUCER SHEATH AND DILATOR
K971165 · Boston Scientific Corp · Jul 1997
MODEL 6495 BIPOLAR TEMPORARY PACING LEAD
K963898 · Medtronic Vascular · Jul 1997
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
RV PACING LEAD
K962467 · Abbott Laboratories · Sep 1996