Cleared Traditional

K973360 - MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLA...

K973360 is the FDA 510(k) clearance for MEDTRONIC MODEL 6416 TRANSVENOUS BIPOLA... by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code LDF) cleared through the Traditional 510(k) pathway after a 260-day FDA review.

K973360 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
260d
Days
Class 2
Risk

K973360 is an FDA 510(k) clearance for the MEDTRONIC MODEL 6416 TRANSVENOUS 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 May 26, 1998 after a review of 260 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

Submission Details

510(k) Number K973360 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 08, 1997
Decision Date May 26, 1998
Days to Decision 260 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
135d slower than avg
Panel avg: 125d · This submission: 260d
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 76
Devices cleared under the same product code (LDF) and FDA review panel - the closest regulatory comparables to K973360.
MODEL 6492 UNIPOLAR TEMPORARY ATRIAL PACING LEAD
K012458 · Medtronic Vascular · Aug 2001
MODEL 6494 UNIPOLAR TEMPORARY MYOCARDIAL PACING WIRE
K012459 · Medtronic Vascular · Aug 2001
MODEL 6495 BIPOLAR TEMPORARY MYOCARDIAL PACING LEAD
K012460 · Medtronic Vascular · Aug 2001
TEMPORARY CARDIAC PACING WIRE
K980503 · Ethicon, Inc. · Apr 1998
SAFPACE SYSTEM
K955829 · B.Braun Medical, Inc. · Nov 1997
INTRODUCER SHEATH AND DILATOR
K971165 · Boston Scientific Corp · Jul 1997