Cleared Traditional

K101570 - HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS

K101570 is an FDA 510(k) clearance for HYPERGLIDE AND HYPERFORM OCCLUSION BALL..., manufactured by Micro Therapeutics Dba Ev3 Neurovascular. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 39-day FDA review.

K101570 · Micro Therapeutics Dba Ev3 Neurovascular · Cardiovascular device
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Jul 2010
Decision
39d
Days
Class 2
Risk

K101570 is an FDA 510(k) clearance for the HYPERGLIDE AND HYPERFORM OCCLUSION BALLOON SYSTEMS. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Micro Therapeutics Dba Ev3 Neurovascular (Irvine, US). The FDA issued a Cleared decision on July 13, 2010 after a review of 39 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. 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 Micro Therapeutics Dba Ev3 Neurovascular devices

FDA 510(k) Submission Details - K101570

510(k) Number K101570 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2010
Decision Date July 13, 2010
Days to Decision 39 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
86d faster than avg
Panel avg: 125d · This submission: 39d
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 62
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K101570.
PTS-X SIZING BALLOON CATHETER
K110903 · NuMED, Inc. · Apr 2011
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
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