Cleared Traditional

K160598 - REBOA Balloon Catheter

K160598 is an FDA 510(k) clearance for REBOA Balloon Catheter, manufactured by NuMED, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K160598 · NuMED, Inc. · Cardiovascular device
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Jun 2016
Decision
110d
Days
Class 2
Risk

K160598 is an FDA 510(k) clearance for the REBOA Balloon Catheter. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by NuMED, Inc. (Hopkinton, US). The FDA issued a Cleared decision on June 20, 2016 after a review of 110 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 NuMED, Inc. devices

FDA 510(k) Submission Details - K160598

510(k) Number K160598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 2016
Decision Date June 20, 2016
Days to Decision 110 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
15d faster than avg
Panel avg: 125d · This submission: 110d
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 K160598.
ER-REBOA Catheter
K172790 · Prytime Medical Devices, Inc. · Nov 2017
ER-REBOA Catheter
K170411 · Prytime Medical Devices, Inc. · Apr 2017
RenovoCath
K160067 · Renovorx, Inc. · Mar 2017
Bridge Occlusion Balloon
K153530 · Spectranetics, Inc. · Feb 2016
Pruitt F3-S Polyurethane Carotid Shunt
K152833 · LeMaitre Vascular, Inc. · Jan 2016
Fogarty Occlusion Catheter
K152762 · Edwards Lifesciences, LLC · Nov 2015