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FDA 510(k)

pREBOA-PRO Catheter

K-Number: K243795 · 2025-09-05

ApplicantPrytime Medical Devices, Inc.
Decision Date2025-09-05
Product CodeMJN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

pREBOA-PRO Catheter is a medical device manufactured by Prytime Medical Devices, Inc.. It received FDA 510(k) clearance on 2025-09-05 under approval number K243795. The device is classified under product code MJN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the pREBOA-PRO Catheter?

pREBOA-PRO Catheter is a medical device that received FDA 510(k) clearance on 2025-09-05. It is manufactured by Prytime Medical Devices, Inc.. The 510(k) number is K243795.

When was pREBOA-PRO Catheter approved by the FDA?

pREBOA-PRO Catheter received FDA 510(k) clearance on 2025-09-05, under approval number K243795.

What company makes pREBOA-PRO Catheter?

pREBOA-PRO Catheter is manufactured by Prytime Medical Devices, Inc..

What is the FDA product code for pREBOA-PRO Catheter?

The FDA product code for pREBOA-PRO Catheter is MJN.

Other Devices by Prytime Medical Devices, Inc.

K172790ER-REBOA Catheter K170411ER-REBOA Catheter K200459pREBOA-PRO Catheter K193440ER-REBOA PLUS Catheter

Related Devices (Code: MJN)

K160598REBOA Balloon CatheterNuMED, Inc. K153530Bridge Occlusion BalloonSpectranetics, Inc. K152833Pruitt F3-S Polyurethane Carotid ShuntLeMaitre Vascular, Inc. K172790ER-REBOA CatheterPrytime Medical Devices, Inc. K170411ER-REBOA CatheterPrytime Medical Devices, Inc. K160067RenovoCathRenovorx, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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