Cleared Special

K132990 - OCCLUSION BALLOON CATHETER

K132990 is an FDA 510(k) clearance for OCCLUSION BALLOON CATHETER, manufactured by Boston Scientific Corp. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Special 510(k) pathway after a 28-day FDA review.

K132990 · Boston Scientific Corp · Cardiovascular device
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Oct 2013
Decision
28d
Days
Class 2
Risk

K132990 is an FDA 510(k) clearance for the OCCLUSION BALLOON CATHETER. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on October 22, 2013 after a review of 28 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 Boston Scientific Corp devices

FDA 510(k) Submission Details - K132990

510(k) Number K132990 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2013
Decision Date October 22, 2013
Days to Decision 28 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
97d faster than avg
Panel avg: 125d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K132990.
Pruitt F3-S Carotid Shunt
K143454 · LeMaitre Vascular, Inc. · Aug 2015
EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · Boston Scientific Corp · Jul 2014
LEMAITRE 8F OCCLUSION CATHETER
K132022 · LeMaitre Vascular, Inc. · Nov 2013
PTS-X SIZING BALLOON CATHETER
K131869 · NuMED, Inc. · Aug 2013
TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT
K122576 · Stryker Neurovascular · Jan 2013
SCEPTER C OCCLUSION BALLOON CATHETER
K121785 · MicroVention, Inc. · Aug 2012