Cleared Traditional

K091458 - HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104

K091458 is an FDA 510(k) clearance for HYPERGLIDE OCCLUSION BALLOON SYSTEM, manufactured by Ev3 Neurovascular. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 150-day FDA review.

K091458 · Ev3 Neurovascular · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
150d
Days
Class 2
Risk

K091458 is an FDA 510(k) clearance for the HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODE.... Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on October 15, 2009 after a review of 150 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4450 - 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 Ev3 Neurovascular devices

FDA 510(k) Submission Details - K091458

510(k) Number K091458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2009
Decision Date October 15, 2009
Days to Decision 150 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
25d slower than avg
Panel avg: 125d · This submission: 150d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 63
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K091458.
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
FOGARTY OCCLUSION CATHETER
K093911 · Edwards Lifesciences, LLC · Jan 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