Cleared Traditional

K041338 - MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES (FDA 510(k) Clearance)

Class I Cardiovascular device.

K041338 · Medtronic Vascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
60d
Days
Class 1
Risk

K041338 is an FDA 510(k) clearance for the MEDTRONIC OCTOPUS TE STABILIZER & ACCESSORIES. Classified as Stabilizer, Heart (product code MWS), Class I - General Controls.

Submitted by Medtronic Vascular (Brooklyn Park, US). The FDA issued a Cleared decision on July 19, 2004 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - 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 K041338 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2004
Decision Date July 19, 2004
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MWS Stabilizer, Heart
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.