Identifiers
- 510(k) Number
- K200459 FDA 510(k)
- FDA Product Code
- MJN FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The pREBOA-PRO Catheter is an intravascular occluding catheter designed for temporary use in the aorta. It is indicated for partial aortic occlusion in resuscitative endovascular balloon occlusion of the aorta (REBOA) procedures.
The device is supplied sterile and intended for single-use. It is used in clinical settings for hemorrhage control and has received FDA 510(k) clearance under product code MJN and regulation number 870.4450.
Frequently asked questions
What is the pREBOA-PRO Catheter used for?
The pREBOA-PRO Catheter is designed for temporary use in the aorta to achieve partial aortic occlusion during resuscitative endovascular balloon occlusion of the aorta (REBOA) procedures, which are performed to control hemorrhage in clinical settings.
Is the pREBOA-PRO Catheter sterile and intended for single-use?
Yes, the pREBOA-PRO Catheter is supplied sterile and is intended for single-use only, meaning it should not be reprocessed or reused after initial deployment to ensure patient safety and device integrity.
What regulatory pathway was used for the pREBOA-PRO Catheter?
The pREBOA-PRO Catheter received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device under the traditional review process.
What product code and regulation number apply to the pREBOA-PRO Catheter?
The device is classified under product code MJN and regulation number 870.4450, which pertains to intravascular occluding catheters for temporary use in the cardiovascular system.
Who manufactures the pREBOA-PRO Catheter and where is it located?
The pREBOA-PRO Catheter is manufactured by Prytime Medical Devices, Inc., located at 229 N. Main St., Boerne, TX 78006, United States.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: pREBOA-PRO - Prytime Medical, Prytime Medical, Prytime's pREBOA-Pro Catheter Receives Clearance for Extended Duration, Prytime Medical Devices Receives World's First Extended Duration FDA ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K200459 | Class II | Active |
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Manufacturer
- Manufacturer
- Prytime Medical Devices Inc.
- FDA Applicant
- Prytime Medical Devices, Inc.
Sources (1)
- FDA 510(k) K200459 24 fields · synced Oct 6, 2026