Cleared Traditional

K170411 - ER-REBOA Catheter (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 89
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K170411.
pREBOA-PRO Catheter
K243795 · Prytime Medical Devices, Inc. · Sep 2025
Bridge Plus Occlusion Balloon (590-002)
K251358 · Philips Image Guided Therapy Devices · Jun 2025
preCARDIA Occlusion System
K221294 · Abiomed, Inc. · Jun 2023
LANDMARK REBOA Catheter
K214060 · Zien Medical Technologies, Inc. · Sep 2022
Fogarty Occlusion Catheter
K211610 · Edwards Lifesciences, LLC · Feb 2022
RenovoCath
K212324 · Renovorx, Inc. · Aug 2021