Cleared Special

K100063 - HYPERFORM OCCLUSION BALLOON CATHETER

K100063 is the FDA 510(k) clearance for HYPERFORM OCCLUSION BALLOON CATHETER by Ev3, Inc.. It is a Class 2 Cardiovascular device (product code MJN) cleared through the Special 510(k) pathway after a 22-day FDA review.

K100063 · Ev3, Inc. · Cardiovascular device
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Feb 2010
Decision
22d
Days
Class 2
Risk

K100063 is an FDA 510(k) clearance for the HYPERFORM OCCLUSION BALLOON CATHETER, HYPERGLIDE OCCLUSION BALLOON CATHETER, .... Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Ev3, Inc. (Irvine, US). The FDA issued a Cleared decision on February 2, 2010 after a review of 22 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 Ev3, Inc. devices

Submission Details

510(k) Number K100063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 11, 2010
Decision Date February 02, 2010
Days to Decision 22 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
103d faster than avg
Panel avg: 125d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 41
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K100063.
SCEPTER XC OCCLUSION BALLOON CATHETER
K113698 · MicroVention, Inc. · Jan 2012
SCEPTER C OCCLUSION BALLOON CATHETER
K110741 · MicroVention, Inc. · Sep 2011
PTS-X SIZING BALLOON CATHETER
K110903 · NuMED, Inc. · Apr 2011
FOGARTY OCCLUSION CATHETER
K093911 · Edwards Lifesciences, LLC · Jan 2010
HYPERGLIDE OCCLUSION BALLOON SYSTEM
K090728 · Ev3, Inc. · Apr 2009
GORE BALLOON SHEATH
K070770 · W.L. Gore & Associates, Inc. · Jun 2007