Cleared Traditional

K915724 - MODEL 6984M LEAD EXTENDER KIT

K915724 is an FDA 510(k) clearance for MODEL 6984M LEAD EXTENDER KIT, manufactured by Medtronic Vascular. The device is a Class 2 Cardiovascular device with product code DTD cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K915724 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1992
Decision
60d
Days
Class 2
Risk

K915724 is an FDA 510(k) clearance for the MODEL 6984M LEAD EXTENDER KIT. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Medtronic Vascular (Minneapolis, US). The FDA issued a Cleared decision on February 18, 1992 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3620 - 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

FDA 510(k) Submission Details - K915724

510(k) Number K915724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1991
Decision Date February 18, 1992
Days to Decision 60 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
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DTD Device Classification - Class 2, Special Controls

Product Code DTD Pacemaker Lead Adaptor
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.3620
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 - DTD Pacemaker Lead Adaptor

All 96
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K915724.
BK-A
K970204 · Biotronik, Inc. · Apr 1997
BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM
K934899 · Telectronics Pacing Systems, Inc. · May 1994
MISCELLANEOUS PACING LEAD
K925168 · Oscor Medical Corp. · May 1994
UNIPOLAR UPSIZING ADAPTOR
K912773 · Telectronics Pacing Systems, Inc. · Oct 1991
LEAD TERMINAL PIN CAPS, VARIOUS MODELS
K911142 · Biotronik, GmbH & Co. · Aug 1991
MODELS 5866-24M/5866-38M/5866-40M/6986M ADAPT KIT
K911302 · Medtronic Vascular · Jul 1991