Cleared Traditional

K110741 - SCEPTER C OCCLUSION BALLOON CATHETER

K110741 is the FDA 510(k) clearance for SCEPTER C OCCLUSION BALLOON CATHETER by MicroVention, Inc.. It is a Class 2 Cardiovascular device (product code MJN) cleared through the Traditional 510(k) pathway after a 197-day FDA review.

K110741 · MicroVention, Inc. · Cardiovascular device
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Sep 2011
Decision
197d
Days
Class 2
Risk

K110741 is an FDA 510(k) clearance for the SCEPTER C OCCLUSION BALLOON CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by MicroVention, Inc. (Tistin, US). The FDA issued a Cleared decision on September 29, 2011 after a review of 197 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 MicroVention, Inc. devices

Submission Details

510(k) Number K110741 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2011
Decision Date September 29, 2011
Days to Decision 197 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
72d slower than avg
Panel avg: 125d · This submission: 197d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 39
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K110741.
PTS-X SIZING BALLOON CATHETER
K131869 · NuMED, Inc. · Aug 2013
SCEPTER C OCCLUSION BALLOON CATHETER
K121785 · MicroVention, Inc. · Aug 2012
SCEPTER XC OCCLUSION BALLOON CATHETER
K113698 · MicroVention, Inc. · Jan 2012
PTS-X SIZING BALLOON CATHETER
K110903 · NuMED, Inc. · Apr 2011
FOGARTY OCCLUSION CATHETER
K093911 · Edwards Lifesciences, LLC · Jan 2010
GORE BALLOON SHEATH
K070770 · W.L. Gore & Associates, Inc. · Jun 2007