Cleared Traditional

K200459 - pREBOA-PRO Catheter

K200459 is an FDA 510(k) clearance for pREBOA-PRO Catheter, manufactured by Prytime Medical Devices, Inc.. The device is a Class 2 Cardiovascular device with product code MJN cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K200459 · Prytime Medical Devices, Inc. · Cardiovascular device
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Jun 2020
Decision
99d
Days
Class 2
Risk

K200459 is an FDA 510(k) clearance for the pREBOA-PRO 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 June 3, 2020 after a review of 99 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 Prytime Medical Devices, Inc. devices

FDA 510(k) Submission Details - K200459

510(k) Number K200459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 2020
Decision Date June 03, 2020
Days to Decision 99 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
26d faster than avg
Panel avg: 125d · This submission: 99d
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 59
Devices cleared under the same product code (MJN) and FDA review panel - the closest regulatory comparables to K200459.
Neurescue device
K210358 · Neurescue Aps · May 2021
COBRA-OS Kit
K201652 · Front Line Medical Technologies, Inc. · Feb 2021
Bridge Occlusion Balloon
K203540 · Spectranetics, Inc. · Dec 2020
Gatekeeper Balloon Catheter
K192786 · Arch Catheter, LLC · Apr 2020
ER-REBOA PLUS Catheter
K193440 · Prytime Medical Devices, Inc. · Jan 2020
RenovoCath
K191606 · Renovorx, Inc. · Aug 2019