Cleared Traditional

K110741 - SCEPTER C OCCLUSION BALLOON CATHETER

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

K110741 · MicroVention, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K110741

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.

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 73
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K110741.
SCEPTER C OCCLUSION BALLOON CATHETER
K121785 · MicroVention, Inc. · Aug 2012
SCEPTER XC OCCLUSION BALLOON CATHETER
K113698 · MicroVention, Inc. · Jan 2012
TAPAS CATHETER
K112219 · Thermopeutix, Inc. · Nov 2011
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