Cleared Traditional

ER-REBOA Catheter (K170411) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K170411 · Prytime Medical Devices, Inc. · Cardiovascular device
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Apr 2017
Decision
53d
Days
Class 2
Risk

K170411 is an FDA 510(k) clearance for the ER-REBOA Catheter. Classified as Catheter, Intravascular Occluding, Temporary (product code MJN), Class II - Special Controls.

Submitted by Prytime Medical Devices, Inc. (Boerne, US). The FDA issued a Cleared decision on April 4, 2017 after a review of 53 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Prytime Medical Devices, Inc. devices

Submission Details

510(k) Number K170411 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2017
Decision Date April 04, 2017
Days to Decision 53 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 125d · This submission: 53d
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 25
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K170411.
Pruitt F3 Carotid Shunt, 10 Fr, Pruitt F3 Carotid Shunt, 9 Fr, Pruitt F3 Carotid Shunt, 8 Fr
K182916 · Lemaitre Vascular · Nov 2018
Sniper Infusion Catheter with Balloon Occlusion
K180904 · Embolx, Inc. · Jun 2018
GORE Molding and Occlusion Balloon Catheter
K172567 · W. L. Gore and Associates, Inc. · Jan 2018
Fogarty Occlusion Catheter
K152762 · Edwards Lifesciences, LLC · Nov 2015
EQUALIZER OCCLUSION BALLOON CATHETER
K140273 · Boston Scientific Corp · Jul 2014
OCCLUSION BALLOON CATHETER
K132990 · Boston Scientific Corp · Oct 2013