Cleared Traditional

K080861 - MICRUS ASCENT OCCLUSION BALLOON CATHETER

K080861 is an FDA 510(k) clearance for MICRUS ASCENT OCCLUSION BALLOON CATHETER, manufactured by Micrus Endovascular Corporation. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K080861 · Micrus Endovascular Corporation · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
153d
Days
Class 2
Risk

K080861 is an FDA 510(k) clearance for the MICRUS ASCENT OCCLUSION BALLOON CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Micrus Endovascular Corporation (San Jose, US). The FDA issued a Cleared decision on August 27, 2008 after a review of 153 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 Micrus Endovascular Corporation devices

FDA 510(k) Submission Details - K080861

510(k) Number K080861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 27, 2008
Decision Date August 27, 2008
Days to Decision 153 days
Submission Type Traditional
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
28d slower than avg
Panel avg: 125d · This submission: 153d
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 59
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K080861.
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
GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
K081454 · Possis Medical, Inc. · Jun 2008
FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05
K071367 · LeMaitre Vascular, Inc. · Aug 2007
GORE BALLOON SHEATH
K070770 · W.L. Gore & Associates, Inc. · Jun 2007