Cleared Special

K093911 - FOGARTY OCCLUSION CATHETER

K093911 is an FDA 510(k) clearance for FOGARTY OCCLUSION CATHETER, manufactured by Edwards Lifesciences, LLC. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Special 510(k) pathway after a 30-day FDA review.

K093911 · Edwards Lifesciences, LLC · Cardiovascular device
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Jan 2010
Decision
30d
Days
Class 2
Risk

K093911 is an FDA 510(k) clearance for the FOGARTY OCCLUSION CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Edwards Lifesciences, LLC (Irvine, US). The FDA issued a Cleared decision on January 21, 2010 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Edwards Lifesciences, LLC devices

FDA 510(k) Submission Details - K093911

510(k) Number K093911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2009
Decision Date January 21, 2010
Days to Decision 30 days
Submission Type Special
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
95d faster than avg
Panel avg: 125d · This submission: 30d
Pathway characteristics
Modification to existing cleared device.

MJN Device Classification - Class 2, Special Controls

Product Code MJN Catheter, Intravascular Occluding, Temporary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.4450
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 - MJN Catheter, Intravascular Occluding, Temporary

All 59
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K093911.
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7 MM
K103780 · Micrus Endovascular Corporation · Jan 2011
PRUITT CAROTID KIT
K103356 · LeMaitre Vascular, Inc. · Dec 2010
HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER MODEL
K100063 · Ev3, Inc. · Feb 2010
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00
K091504 · Micrus Endovascular Corporation · Jun 2009
HYPERGLIDE OCCLUSION BALLOON SYSTEM
K090728 · Ev3, Inc. · Apr 2009
MICRUS ASCENT OCCLUSION BALLOON CATHETER
K080861 · Micrus Endovascular Corporation · Aug 2008