Prytime Medical Devices, Inc. is one of 5511 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Prytime Medical Devices, Inc. - FDA 510(k) Cleared Devices
Recent clearances: pREBOA-PRO Catheter, pREBOA-PRO Catheter, ER-REBOA PLUS Catheter
5
Total
5
Cleared
0
Denied
Prytime Medical Devices, Inc. has 5 FDA 510(k) cleared medical devices. Based in Boerne, US.
Latest FDA clearance: Sep 2025. Active since 2017. Primary specialty: Cardiovascular.
Browse the FDA 510(k) cleared devices submitted by Prytime Medical Devices, Inc. Filter by specialty or product code using the sidebar.
1 device has linked clinical trial registered on ClinicalTrials.gov.
FDA 510(k) Regulatory Record - Prytime Medical Devices, Inc.
5 devices
Cleared
CT
Sep 05, 2025
pREBOA-PRO Catheter
Cardiovascular
269d
Cleared
Jun 03, 2020
pREBOA-PRO Catheter
Cardiovascular
99d
Cleared
Jan 09, 2020
ER-REBOA PLUS Catheter
Cardiovascular
29d
Cleared
Nov 08, 2017
ER-REBOA Catheter
Cardiovascular
54d
Cleared
Apr 04, 2017
ER-REBOA Catheter
Cardiovascular
53d