pREBOA-PRO Catheter

FDA 510(k) K243795 · Prytime Medical Devices, Inc.

Substantially Equivalent

510(k) numberK243795

Submission

Device name
pREBOA-PRO Catheter
Applicant
Prytime Medical Devices, Inc.
Boerne, TX, US
Received
December 10, 2024
Decision date
September 5, 2025
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MJN – Catheter, Intravascular Occluding, Temporary
Device class
Class II (moderate risk)
Regulation
21 CFR 870.4450
Specialty
Cardiovascular

Other 510(k)s with product code MJN

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K251358Bridge Plus Occlusion Balloon (590-002)MJN · Traditional Philips Image Guided Therapy Devices06/24/2025SE
K221294preCARDIA Occlusion SystemMJN · Traditional Abiomed, Inc.06/30/2023SESU
K214060LANDMARK REBOA CatheterMJN · Traditional Zien Medical Technologies, Inc.09/19/2022SE
K211610Fogarty Occlusion CatheterMJN · Traditional Edwards Lifesciences, LLC02/14/2022SE
K212324RenovoCathMJN · Special Renovorx, Inc.08/23/2021SE
K210602AortaSTAT Occlusion DeviceMJN · Traditional Renalpro Medical, Inc.07/09/2021SE
K210358Neurescue deviceMJN · Traditional Neurescue Aps05/21/2021SE
K201652COBRA-OS KitMJN · Traditional Front Line Medical Technologies, Inc.02/22/2021SESK
K203540Bridge Occlusion BalloonMJN · Special Spectranetics, Inc.12/23/2020SE
K200459pREBOA-PRO CatheterMJN · Traditional Prytime Medical Devices, Inc.06/03/2020SE

More from Prytime Medical Devices, Inc.

510(k)DeviceDecision
K200459pREBOA-PRO CatheterMJN · Traditional 06/03/2020SE
K193440ER-REBOA PLUS CatheterMJN · Special 01/09/2020SE
K172790ER-REBOA CatheterMJN · Traditional 11/08/2017SE
K170411ER-REBOA CatheterMJN · Traditional 04/04/2017SE

Questions and answers

When was pREBOA-PRO Catheter cleared by the FDA?

pREBOA-PRO Catheter (K243795) received a 510(k) decision of Substantially Equivalent on September 5, 2025, 269 days after the submission was received.

What is the product code of K243795?

The FDA product code is MJN – Catheter, Intravascular Occluding, Temporary, a Class II (moderate risk) device regulated under 21 CFR 870.4450.