Cleared Traditional

pREBOA-PRO Catheter

K243795 · Prytime Medical Devices, Inc. · Cardiovascular

Sep 2025

Decision

269d

Days

Class 2

Risk

About This 510(k) Submission

K243795 is an FDA 510(k) clearance for the pREBOA-PRO Catheter, a Catheter, Intravascular Occluding, Temporary (Class II — Special Controls, product code MJN), submitted by Prytime Medical Devices, Inc. (Boerne, US). The FDA issued a Cleared decision on September 5, 2025, 269 days after receiving the submission on December 10, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4450.

Submission Details

510(k) Number	K243795 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 10, 2024
Decision Date	September 05, 2025
Days to Decision	269 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF