Cleared Traditional

K811349 - MODEL 5866-24 LEAD ADAPTOR KIT

K811349 is the FDA 510(k) clearance for MODEL 5866-24 LEAD ADAPTOR KIT by Medtronic Vascular. It is a Class 2 Cardiovascular device (product code DTD) cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K811349 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1981
Decision
48d
Days
Class 2
Risk

K811349 is an FDA 510(k) clearance for the MODEL 5866-24 LEAD ADAPTOR KIT. Classified as Pacemaker Lead Adaptor (product code DTD), Class II - Special Controls.

Submitted by Medtronic Vascular (Walker, US). The FDA issued a Cleared decision on June 30, 1981 after a review of 48 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

Submission Details

510(k) Number K811349 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 1981
Decision Date June 30, 1981
Days to Decision 48 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d faster than avg
Panel avg: 125d · This submission: 48d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 84
Devices cleared under the same product code (DTD) and FDA review panel - the closest regulatory comparables to K811349.
INTERMEDICS ADAPTAID STEP-DOWN ADAPTER
K812812 · Intermedics, Inc. · Oct 1981
ADAPTAID LEAD ADAPTER, #365-17
K811920 · Intermedics, Inc. · Aug 1981
ADAPTAID LEAD ADAPTER #365-25
K811938 · Intermedics, Inc. · Aug 1981
PACEMAKER LEAD ADAPTER
K810551 · Pacesetter Systems · Apr 1981
IMPLANTABLE PACEMAKER LEAD ADAPTER
K810245 · Intermedics, Inc. · Mar 1981
PACEMAKER LEAD ADAPTOR MODEL 431
K802407 · Pacesetter Systems · Oct 1980