Cleared Traditional

K122576 - TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT

K122576 is an FDA 510(k) clearance for TRANSFORM OCCLUSION BALLOON CATHETER (C..., manufactured by Stryker Neurovascular. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K122576 · Stryker Neurovascular · Cardiovascular device
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Jan 2013
Decision
141d
Days
Class 2
Risk

K122576 is an FDA 510(k) clearance for the TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Stryker Neurovascular (Fremont, US). The FDA issued a Cleared decision on January 11, 2013 after a review of 141 days - within the typical 510(k) review window.

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 Stryker Neurovascular devices

FDA 510(k) Submission Details - K122576

510(k) Number K122576 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 2012
Decision Date January 11, 2013
Days to Decision 141 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
16d slower than avg
Panel avg: 125d · This submission: 141d
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 77
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K122576.
LEMAITRE 8F OCCLUSION CATHETER
K132022 · LeMaitre Vascular, Inc. · Nov 2013
OCCLUSION BALLOON CATHETER
K132990 · Boston Scientific Corp · Oct 2013
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
TAPAS CATHETER
K112219 · Thermopeutix, Inc. · Nov 2011