K243795 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 September 5, 2025 after a review of 269 days - an extended review cycle.
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
NCT00459160
Unknown
Interventional
A Comparison of Two Target Mean Arterial Pressures in the Resuscitation of Hypotensive Trauma Patients
A Comparison of Two Target Mean Arterial Pressures in the Resuscitation of Hypotensive Trauma Patients Undergoing Laparotomy or Thoracotomy for Trauma: A Prospective Randomized Controlled Clinical Trial
| Condition studied |
Hemorrhagic Shock; Trauma; Wounds, Penetrating; Shock, Traumatic; Multiple Trauma |
| Study design |
Parallel |
| Eligibility |
All sexes
· 12 Years+
|
| Principal investigator |
Matthew M Carrick, MD |
| Sponsor |
Baylor College of Medicine
|
Started 2007-07-01
→
Primary completion 2011-07-01
Primary outcome
30 day survival
Secondary outcome
Sequential Organ Failure Assessment (SOFA) score
View full study on ClinicalTrials.gov